Chronic Hepatitis BPhase 1NCT07918456

A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.

A Phase 1 study testing CPU-YL01 Injection Intramuscular administration in people with Chronic Hepatitis B, run by Jiangsu Chuangyuan Life Science and Technology Co., Ltd. at 4 sites in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 1 trial. It aims to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CPU-YL01 injection in chronic hepatitis B patients who have received nucleos(t)ide analog therapy. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Hepatitis B
What is being tested?: CPU-YL01 Injection Intramuscular administration
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 4 sitesChina
Study dates: 3 Jul 2026to 3 Jul 2028
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntarily sign the informed consent form (ICF), understand this study, and be willing and able to comply with and complete all trial procedures;
Open to all genders; age range: 18-70 years(inclusive);
The body mass index (BMI) ranges from 18 to 30 kg/m2(including the boundary values);
Clinically diagnosed chronic hepatitis B (serum HBsAg positivity for ≥6 months; outpatient medical records, inpatient medical records, or laboratory test results may serve as evidence);
During the screening phase, the HBsAg test result was ≤10,000 IU/mL (for participants in single-dose studies); or the HBsAg test result was ≤3,000 IU/mL (for participants in multiple-dose studies);
Patients currently receiving a stable dose of monotherapy or combination therapy with one or two nucleos(t)ide analogs for hepatitis B virus (HBV) treatment are required to have had no changes in their nucleos(t)ide analog regimen during the preceding 6 months, and no plans to alter their nucleos(t)ide analog regimen during the trial period. The eligible treatment options are limited to the following five agents: tenofovir alafenamide fumarate (TAF), teltenofovir mesylate (TMF), tenofovir disoproxil fumarate (TDF), prafenomide mesylate tablets (formerly known as paradenomide mesylate tablets; brand name: Xinshumu), or entecavir (ETV);
The HBV DNA test result during the screening phase was negative (below the lower detection limit of the local research center);
Male trial participants and female trial participants of childbearing age shall agree to use effective contraceptive measures from the time of signing the informed consent form until 6 months after the last dose.

Who cannot join

A history of liver cirrhosis (confirmed by liver biopsy), or the presence of complications such as gastroesophageal variceal bleeding, hepatic encephalopathy, or ascites, or a liver stiffness measurement>12.4 kPa during screening;
Presence of other clinically significant liver diseases other than chronic hepatitis B, such as autoimmune hepatitis, toxic hepatitis, hemochromatosis, alcoholic liver disease, drug-induced hepatitis, α1-antitrypsin deficiency, Wilson's disease, etc.;
Use of immunosuppressants or immunomodulators (e.g., thymus) within 6 months prior to the first dose Patients taking peptides or cytotoxic agents, or those who have received corticosteroid therapy (excluding topical, inhalational, or ophthalmic treatments) for at least one week within 6 months prior to the first dose, or those who have had a history of vaccination within 1 month prior to screening or have planned to receive vaccinations during the trial period;
Prior to the first dose, the subject has received interferon or peginterferon therapy within the preceding 6 months, or plans to receive interferon or peginterferon therapy during the trial period;
Positive for hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies, or positive for Treponema pallidum (TP) antibodies with confirmatory positive results on the rapid plasma reagin (RPR) test;
Exclusion criteria include a history of malignant tumor or recurrence within the 5 years prior to the first dose, except for specific cancers that can be cured by surgical resection (e.g., non-melanoma skin cancer, cervical intraepithelial neoplasia, thyroid tumors, breast tumors, etc., that have already been treated and show no signs of recurrence);

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Has previously undergone organ transplantation;
Patients with a prior history of myocarditis, pericarditis, or idiopathic cardiomyopathy;
Participants who, at the time of screening, suffer from systemic severe diseases affecting other organs-including but not limited to the gastrointestinal, respiratory, renal, neurological, hematological, endocrine, oncological, or immunological systems (including but not limited to immunodeficiency or immunosuppression), as well as psychiatric or cardiovascular and cerebrovascular diseases-and who have been determined by the study physician to be unsuitable for participation in this trial;
Suffering from a progressive neurological disorder;
Patients with poorly controlled diabetes [fasting plasma glucose>7.0 mmol/L and/or HbA1c ≥7.5%] or hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), for whom the investigator determines that they are unsuitable to participate in this trial;
Patients with a severe allergic constitution, a history of allergies to multiple foods or medications, or a known allergy to the test drug or its excipients;
Subjects who exhibit significant abnormalities in laboratory tests or electrocardiogram (ECG) findings during the screening phase, and whom the investigator determines to be unsuitable for participation in this trial, including but not limited to:
ALT or AST ≥ 2×ULN;
TBil ≥ 2×ULN and direct bilirubin (DBil)> 1.5×ULN;
Albumin <38 g/L;
Platelet count <125×10*9/L;
Absolute neutrophil count <1.5×10*9/L;
Prothrombin time (PT)>3s, or international normalized ratio (INR)>1.3;
Creatinine clearance (using the Cockcroft-Gault formula) <60 mL/min;
Alpha-fetoprotein (AFP)> 20 μg/L;
QTcF> 450 ms (men) or> 470 ms (women);
A history of drug use or alcohol abuse [weekly alcohol consumption exceeding 14 alcohol units (1 alcohol unit = 360 mL of beer, 150 mL of wine, or 45 mL of distilled spirits)];
Having participated in other drug clinical trials and used trial drugs, or having participated in clinical trials of medical devices or vaccines, within 3 months prior to the first dose administration or within 5 drug half-life periods (whichever period is longer);
In this trial, participants who previously participated in the single-dose trial of CPU-YL01 may be re-screened for enrollment during the multiple-dose trial phase; the time limit requirements for prior trial participation of such participants shall be consistent with the exclusion criteria specified in Clause 15.
Women who are pregnant or breastfeeding;
The researchers believe that the subject is unsuitable to participate in this trial due to other reasons.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China4 sites

Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
Beijing Jishuitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 102208
Gulou Hospital, Nanjing University Medical School
Nanjing, Jiangsu, 210008
Henan Province Infectious Disease Hospital (Zhengzhou Sixth People's Hospital)
Zhengzhou, Henan, 450015

Other trials in China

About this study

Official title: A Phase I Clinical Trial to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of CPU-YL01 Injection in Patients With Chronic Hepatitis B

Read the detailed description

This study is a multicenter, randomized, double blind, placebo controlled Phase I clinical trial involving single dose and multiple dose, dose-escalation explorations, aimed at evaluating the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of CPU-YL01 in patients with chronic hepatitis B (CHB) previously treated with nucleos(t)ide analogs (NAs), as well as exploring its effects on biomarkers and immunogenicity, thereby providing a scientific basis for dose selection in Phase II clinical trials. Patients enrolled in this trial must have been previously treated with NAs; during the trial, they shall continue to take their respective NAs at the same regimen including drug class, dosage, and dosing frequency to avoid virological breakthrough due to discontinuation of NAs.

Conditions: Chronic Hepatitis B
Being tested: CPU-YL01 Injection Intramuscular administration, Placebo intramuscular injection
Medical subject headings: Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CPU-YL01 Injection Intramuscular administrationDrug
Single-dose study：Each dose group received a single dose of treatment; on day Day1, subjects in all groups received either the test drug CPU-YL01 or a placebo via intramuscular injection. Tolerance evaluation assessments were conducted on days Day2, Day3, Day8, Day15, Day22, and Day29, respectively.
Multiple-dose study：Each dose group received six administrations, with one administration every 4 weeks, specifically via intramuscular injection of the test drug CPU-YL01 or placebo on days Day1, Day29, Day57, Day85, Day113, and Day141. Tolerance evaluation assessments were conducted before administration on days Day2, Day3, Day8, and Day29; before administration on days Day36, Day57, Day85, Day113, and Day141; and on days Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
Placebo intramuscular injectionDrug
Single-dose study：Each dose group received a single dose of treatment; on day Day1, subjects in all groups received either the test drug CPU-YL01 or a placebo via intramuscular injection. Tolerance evaluation assessments were conducted on days Day2, Day3, Day8, Day15, Day22, and Day29, respectively.
Multiple-dose study：Each dose group received six administrations, with one administration every 4 weeks, specifically via intramuscular injection of the test drug CPU-YL01 or placebo on days Day1, Day29, Day57, Day85, Day113, and Day141. Tolerance evaluation assessments were conducted before administration on days Day2, Day3, Day8, and Day29; before administration on days Day36, Day57, Day85, Day113, and Day141; and on days Day142, Day143, Day148, Day169, Day225, Day281, and Day337.

Study groups in NCT07918456
Study group	Role	What they receive
CPU-YL01 Injection	Experimental	Intramuscular administration Receives: Drug: CPU-YL01 Injection Intramuscular administration
Placbo Injection	Placebo comparator	Intramuscular administration Receives: Drug: Placebo intramuscular injection

What is being measured

The primary outcome is the main question the study is designed to answer.

adverse events [Safety and Tolerability Evaluation Endpoints]
adverse events
Measured: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
serious adverse events [Safety and Tolerability Evaluation Endpoints]
serious adverse events
Measured: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
adverse events of particular concern (AESI) [Safety and Tolerability Evaluation Endpoints]
adverse events of particular concern (AESI)
Measured: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
vital signs-Blood Pressure (mmHg) [Safety and Tolerability Evaluation Endpoints]
vital signs-Blood Pressure (mmHg)
Measured: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose:Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-respiratory rate (breaths/min) [Safety and Tolerability Evaluation Endpoints]
vital signs-respiratory rate (breaths/min)
Measured: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-body temperature (°C) [Safety and Tolerability Evaluation Endpoints]
vital signs-body temperature (°C)
Measured: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-pulse rate (beats/min) [Safety and Tolerability Evaluation Endpoints]
vital signs-pulse rate (beats/min)
Measured: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
physical examination- skin- Color abnormalities-jaundice -The number of participants with or without skin Color abnormalities- jaundice [Safety and Tolerability Evaluation Endpoints]
physical examination- skin-Color abnormalities: jaundice. The number of participants with or without skin Color abnormalities: jaundice will be reported by category.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin- Color abnormalities-pallor- The number of participants with or without skin Color abnormalities: pallor [Safety and Tolerability Evaluation Endpoints]
physical examination- skin- Color abnormalities: pallor. The number of participants with or without skin Color abnormalities: pallor will be reported by category.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Color abnormalities-pigmentation- The number of participants with or without skin Color abnormalities:pigmentation [Safety and Tolerability Evaluation Endpoints]
physical examination- skin-Color abnormalities : pigmentation. The number of participants with or without skin Color abnormalities:pigmentation will be reported by category.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities- rash-The number of participants with or without -Morphological abnormalities: rash [Safety and Tolerability Evaluation Endpoints]
physical examination- skin-Morphological abnormalities: rash . The number of participants with or without -Morphological abnormalities: rash will be reported by category.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities-erythema at injection site -The number of participants with or without -Morphological abnormalities: erythema at injection site [Safety and Tolerability Evaluation Endpoints]
physical examination- skin-Morphological abnormalities: erythema at injection site. The number of participants with or without -Morphological abnormalities: erythema at injection site will be reported by category.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities: induration at injection site- The number of participants with or without -Morphological abnormalities: induration at injection site [Safety and Tolerability Evaluation Endpoints]
physical examination- skin-Morphological abnormalities: induration at injection site. The number of participants with or without -Morphological abnormalities: induration at injection site will be reported by category.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Ocular conjunctiva: assessment for scleral icterus- The number of participants with or without -Ocular conjunctiva-scleral icterus [Safety and Tolerability Evaluation Endpoints]
physical examination-mucous membranes- Ocular conjunctiva: assessment for scleral icterus. The number of participants with or without -Ocular conjunctiva-scleral icterus will be reported by category.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes- Ocular conjunctiva: assessment for conjunctival pallor-The number of participants with or without -Ocular conjunctiva-conjunctival pallor [Safety and Tolerability Evaluation Endpoints]
physical examination-mucous membranes-Ocular conjunctiva: assessment for conjunctival pallor. The number of participants with or without -Ocular conjunctiva-conjunctival pallor will be reported by category.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Oral mucosa: assessment for petechiae-The number of participants with or without Oral mucosa-petechiae [Safety and Tolerability Evaluation Endpoints]
physical examination-mucous membranes-Oral mucosa: assessment for petechiae. The number of participants with or without Oral mucosa-petechiae will be reported by category.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Oral mucosa: assessment for ulceration-The number of participants with or without Oral mucosa-ulceration [Safety and Tolerability Evaluation Endpoints]
physical examination-mucous membranes-Oral mucosa: assessment for ulceration. The number of participants with or without Oral mucosa-ulceration will be reported by category.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes- Oral mucosa: assessment for fungal infection-The number of participants with or without Oral mucosa-fungal infection [Safety and Tolerability Evaluation Endpoints]
physical examination-mucous membranes-Oral mucosa: assessment for fungal infection. The number of participants with or without Oral mucosa-fungal infection will be reported by category.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes- lymph nodes enlargement -The number of participants with or without lymph nodes enlargement [Safety and Tolerability Evaluation Endpoints]
physical examination-lymph nodes enlargement. The number of participants with or without lymph nodes enlargement will be reported by category. (Among participants with enlarged lymph nodes, findings for lymph node consistency, mobility and tenderness will also be summarized.)
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes- Lymph Node Consistency(Participants with Enlarged Lymph Nodes)- The number of participants with lymph node consistency- soft, firm, hard. [Safety and Tolerability Evaluation Endpoints]
physical examination-lymph nodes- Assessment of lymph node consistency (soft, firm, hard).
Among participants with enlarged lymph nodes, lymph node consistency will be assessed (soft, firm, hard). The number of participants in each consistency category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes-assessment for lymph nodes mobility (Participants with Enlarged Lymph Nodes) -The number of participants with lymph node mobility -mobile, fixed. [Safety and Tolerability Evaluation Endpoints]
physical examination-lymph nodes - Assessment of lymph node mobility (mobile / fixed).
Among participants with enlarged lymph nodes, lymph node mobility will be assessed (mobile, fixed). The number of participants in each mobility category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes-assessment for tenderness (Participants with Enlarged Lymph Nodes) -The number of participants with lymph node tenderness tender, non-tender. [Safety and Tolerability Evaluation Endpoints]
physical examination-lymph nodes -assessment for tenderness. Among participants with enlarged lymph nodes, assessment for lymph node tenderness (tender, non-tender). The number of participants in each tenderness category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Face: assessment for dull facies-The number of participants with dull facies [Safety and Tolerability Evaluation Endpoints]
physical examination-head-Face: assessment for dull facies. The number of participants with dull facies will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Face: assessment for facial edema-The number of participants with facial edema [Safety and Tolerability Evaluation Endpoints]
physical examination-head-Face: assessment for facial edema. The number of participants with facial edema will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Eyes: assessment for eyelid edema-The number of participants with eyelid edema [Safety and Tolerability Evaluation Endpoints]
physical examination-head-Eyes: assessment for eyelid edema. The number of participants with eyelid edema will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Eyes: assessment for pupillary light reflex-The number of participants with normal, abnormal pupillary light reflex [Safety and Tolerability Evaluation Endpoints]
physical examination-head-Eyes: assessment for pupillary light reflex. Assessment of pupillary light reflex (normal / abnormal). The number of participants with normal, abnormal pupillary light reflex will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-assessment for alopecia- The number of participants with alopecia [Safety and Tolerability Evaluation Endpoints]
physical examination-head-assessment for alopecia. The number of participants with alopecia will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for Thyroid Enlargement- The number of participants with Thyroid Enlargement [Safety and Tolerability Evaluation Endpoints]
physical examination-neck-assessment for Thyroid Enlargement. The number of participants with Thyroid Enlargement will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for Thyroid nodules-The number of participants with Thyroid nodules [Safety and Tolerability Evaluation Endpoints]
physical examination-neck-assessment for Thyroid nodules. The number of participants with Thyroid nodules will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment of tracheal position-The number of participants with tracheal position midline / deviated [Safety and Tolerability Evaluation Endpoints]
physical examination-neck-assessment of tracheal position (midline / deviated). The number of participants in each category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for nuchal rigidity-The number of participants with nuchal rigidity [Safety and Tolerability Evaluation Endpoints]
physical examination-neck-assessment for nuchal rigidity. The number of participants with nuchal rigidity will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Lungs: assessment of breath sound clarity-The number of participants with lung breath sounds clear, wheezes, rales. [Safety and Tolerability Evaluation Endpoints]
physical examination- chest-Lungs: Assessment of lung breath sounds (clear, wheezes, rales). The number of participants in each category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Heart: assessment of cardiac rhythm regularity-The number of participants with cardiac rhythm regular, irregular. [Safety and Tolerability Evaluation Endpoints]
physical examination- chest-Heart: Assessment of cardiac rhythm (regular / irregular). The number of participants in each category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Heart: assessment of cardiac murmur-The number of participants with cardiac murmur present, absent. [Safety and Tolerability Evaluation Endpoints]
physical examination- chest-Heart: Assessment for cardiac murmur (present / absent). The number of participants in each category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver: assessment of Palpability of Liver Edge Below Right Midclavicular Costal Margin-The number of participants with the liver edge palpable, not palpable. [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-Liver. Abdominal palpation to assess whether the liver edge is palpable below the right midclavicular costal margin (palpable / not palpable). The number of participants in each category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver: Distance of Palpable Liver Edge Below the Right Midclavicular Costal Margin (centimeter)(For participants with a palpable liver edge)[Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-Liver-Distance of Palpable Liver Edge Below the Right Midclavicular Costal Margin (centimeter). For participants with a palpable liver edge below the right midclavicular costal margin, the subcostal distance will be measured and reported in centimeters. This field will be left blank for participants without a palpable liver edge.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver: assessment of hepatic consistency-The number of participants with hepatic consistency soft, firm, hard.(For participants with a palpable liver edge) [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-Liver: assessment of consistency (soft, firm, hard). Among participants with a palpable liver edge below the costal margin, hepatic consistency is assessed (soft, firm, hard). The number of participants in each consistency category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for abdominal wall varices-The number of participants with abdominal wall varices [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-assessment for abdominal wall varices.The number of participants with abdominal wall varices will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for abdominal tenderness-The number of participants with abdominal tenderness [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-assessment for abdominal tenderness.The number of participants with abdominal tenderness will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for rebound tenderness-The number of participants with rebound tenderness. [Safety and Tolerability Evaluation Endpoints
physical examination-abdomen-assessment for rebound tenderness. The number of participants with rebound tenderness will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for shifting dullness (indicative of ascites)-The number of participants-shifting dullness for ascites screening positive, negative. [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-Percussion assessment for shifting dullness for ascites screening (positive / negative). The number of participants in each category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Spleen: assessment of Palpability of Spleen Edge Below Left Midclavicular Costal Margin-The number of participants with the splenic edge palpable, not palpable. [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-Spleen-Abdominal palpation to assess whether the splenic edge is palpable below the left midclavicular costal margin (palpable / not palpable). The number of participants in each category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Spleen: Distance of Palpable Spleen Edge Below the Left Midclavicular Costal Margin (centimeter)(For participants with a palpable splenic edge ) [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-Spleen- Distance of Palpable Spleen Edge Below the Left Midclavicular Costal Margin (centimeter) .For participants with a palpable splenic edge below the left midclavicular costal margin, the subcostal distance will be measured and reported in centimeters. This field will be left blank for participants without a palpable splenic edge.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for bilateral lower extremity edema-The number of participants with bilateral lower extremity edema [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Extremities: assessment for bilateral lower extremity edema. The number of participants with bilateral lower extremity edema will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint erythema-The number of participants with joint erythema [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Extremities: assessment for joint erythema.The number of participants with joint erythema will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint warmth -The number of participants with joint warmth [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Extremities: assessment for joint warmth. The number of participants with joint warmth will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint tenderness -The number of participants with joint tenderness [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Extremities: assessment for joint tenderness. The number of participants with joint tenderness will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint swelling -The number of participants with joint swelling [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Extremities: assessment for joint swelling. The number of participants with joint swelling will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Spine: assessment for deformity The number of participants with Spine deformity. [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Spine: assessment for deformity. The number of participants with Spine deformity. will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: Spine: assessment for tenderness -The number of participants withwith Spine tenderness [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Extremities: assessment for joint swelling. The number of participants with joint swelling will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Spine: assessment for limited range of motion The number of participants with limited range of motion . [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Spine: assessment for limited range of motion. The number of participants with limited range of motion of Spine will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination--assessment of development- The number of participants with development good, fair, poor. [Safety and Tolerability Evaluation Endpoints]
physical examination-assessment of development. General physical examination assessment of development (good, fair, poor).. The number of participants in each category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination--assessment of nutritional status- The number of participants with nutritional status good, fair, poor. [Safety and Tolerability Evaluation Endpoints]
physical examination-assessment of nutritional status. Assessment of nutritional status (good, fair, poor). The number of participants in each category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination--assessment of mental status- The number of participants with mental status alert, drowsy, agitated, comatose. [Safety and Tolerability Evaluation Endpoints]
physical examination-other areas-Assessment of mental status (alert, drowsy, agitated, comatose). The number of participants in each category will be reported.
Measured: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
12-lead electrocardiogram-heart rate [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-heart rate
Measured: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-PR interval [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-PR interval
Measured: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-RR interval [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-RR interval
Measured: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-QRS [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-QRS
Measured: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-QT interval [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-QT interval
Measured: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-QTcF [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-QTcF
Measured: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-electrocardiographic diagnostic results [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-electrocardiographic diagnostic results
Measured: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
Clinical laboratory tests-hematology-red blood cell count (RBC) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-hematology-red blood cell count (RBC)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-Concentration of hemoglobin (HGB) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-hematology-Concentration of hemoglobin (HGB)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-white blood cell count (WBC) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-hematology-white blood cell count (WBC)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-absolute neutrophil count (ANC) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-hematology-absolute neutrophil count (ANC)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-platelet count (PLT) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-hematology-platelet count (PLT)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-Concentration of urine protein (UPRO) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Urinalysis-Concentration of urine protein (UPRO)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-count of urine red blood cells (RBC) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Urinalysis-count of urine red blood cells (RBC)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-count of urine white blood cells (WBC) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Urinalysis-count of urine white blood cells (WBC)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-Concentration of glucose (GLU-U) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Urinalysis-Concentration of glucose (GLU-U)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-Concentration of ketones (KET) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Urinalysis-Concentration of ketones (KET)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of alanine aminotransferase (ALT) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-enzyme activity of alanine aminotransferase (ALT)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of aspartate aminotransferase (AST) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-enzyme activity of aspartate aminotransferase (AST)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of γ-glutamyl transferase(γ-GGT) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-enzyme activity of γ-glutamyl transferase(γ-GGT)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of alkaline phosphatase (ALP) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-enzyme activity of alkaline phosphatase (ALP)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2,Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of cholinesterase (CHE) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-enzyme activity of cholinesterase (CHE)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of albumin (ALB) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests- Blood biochemistry-Concentration of albumin (ALB)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of total protein (TP) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of total protein (TP)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of total bilirubin (TBil) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of total bilirubin (TBil)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of direct bilirubin (DBil) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of direct bilirubin (DBil)
Measured: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of serum creatinine (Cr) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of serum creatinine (Cr)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of serum uric acid (UA) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of serum uric acid (UA)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of urea/blood urea nitrogen (Urea/BUN) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of urea/blood urea nitrogen (Urea/BUN)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of total cholesterol (TC) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of total cholesterol (TC)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of triglycerides (TG) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of triglycerides (TG)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of high-density lipoprotein cholesterol (HDL-C) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of high-density lipoprotein cholesterol (HDL-C)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of low-density lipoprotein cholesterol (LDL-C) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of low-density lipoprotein cholesterol (LDL-C)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of serum glucose (GLU) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of serum glucose (GLU)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of phosphorus ion levels [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of phosphorus ion levels
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of potassium ion levels [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of potassium ion levels
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of sodium ion levels [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of sodium ion levels
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of chloride ion levels [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of chloride ion levels
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of calcium ion levels [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of calcium ion levels
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-prothrombin activity (PTA) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Coagulation profile-prothrombin activity (PTA)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-prothrombin time (PT) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Coagulation profile-prothrombin time (PT)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-Concentration of fibrinogen (FIB) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Coagulation profile-Concentration of fibrinogen (FIB)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-activated partial thromboplastin time (APTT) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Coagulation profile-activated partial thromboplastin time (APTT)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-thrombin time (TT) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Coagulation profile-thrombin time (TT)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests--Concentration of troponinI [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Concentration of troponinI
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests--Concentration of C-reactive protein (CRP) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Concentration of C-reactive protein (CRP)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin G (IgG) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Immunological five-item panel-Concentration of immunoglobulin G (IgG)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin A (IgA) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin A (IgA)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C4 [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C4
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin G (IgG) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin G (IgG)
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C3 [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C3
Measured: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
abdominal ultrasound- liver-Liver size(millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-Liver size (millimeter)
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Hepatic Capsule - The number of participants with hepatic capsule findings normal, abnormal.[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-Abdominal examination for hepatic capsule findings (normal / abnormal). The number of participants in each category will be reported.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Hepatic Parenchymal echotexture - The number of participants with hepatic parenchymal echotexture normal, abnormal.[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-Parenchymal echotexture. Assessment of hepatic parenchymal echotexture (normal / abnormal). The number of participants in each category will be reported.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Portal Vein Internal Diameter (millimeter).[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-Portal Vein Internal Diameter (millimeter)
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-intrahepatic biliary duct dilation-The number of participants with intrahepatic biliary duct dilation .[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-intrahepatic biliary duct dilation. The number of participants with intrahepatic biliary duct dilation will be reported.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-extrahepatic biliary duct dilation-The number of participants with extrahepatic biliary duct dilation .[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-extrahepatic biliary duct dilation.The number of participants with extrahepatic biliary duct dilation will be reported.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Hepatic Solid Space-Occupying Lesion-The number of participants with the presence or absence of hepatic solid space-occupying lesions .[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-Hepatic Solid Space-Occupying Lesion. Abdominal ultrasound assessment for the presence or absence of hepatic solid space-occupying lesions. The number of participants in each category will be reported. Among participants with identified lesions, lesion size and location will be summarized.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Size of Hepatic Solid Space-Occupying Lesions (centimeter).( For participants with hepatic solid space-occupying lesions identified on abdominal ultrasound)[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-Size of Hepatic Solid Space-Occupying Lesions (centimeter) . Among participants with hepatic solid space-occupying lesions identified on abdominal ultrasound, lesion size will be recorded in centimeters. Lesion location will also be documented. This field will be blank for participants without hepatic solid space-occupying lesions.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-gallbladder-Gallbladder wall Thickness(millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-gallbladder-Gallbladder wall Thickness (millimeter)
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-gallbladder-gallstones-The number of participants with the presence or absence of gallstones[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-gallbladder-gallstones. Ultrasound assessment for the presence or absence of gallstones. The number of participants in each category will be reported.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-gallbladder-gallbladder polyps-The number of participants with the presence or absence of gallbladder polyps. [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-gallbladder-gallbladder polyps. Ultrasound assessment for the presence or absence of gallbladder polyps. The number of participants in each category will be reported.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-pancreas-Pancreatic Duct Internal Diameter(millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-pancreas-Pancreatic Duct Internal Diameter(millimeter).Ultrasound measurement of pancreatic duct internal diameter. Measurements will be recorded and reported in millimeters.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-pancreas-Pancreatic Contour-The number of participants with pancreatic contour normal, abnormal. [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-pancreas-Pancreatic Contour. Ultrasound assessment of pancreatic contour (normal / abnormal). The number of participants in each category will be reported.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-spleen-Spleen Longitudinal Diameter (millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- spleen-Spleen Longitudinal Diameter (millimeter). Ultrasound measurement of splenic longitudinal diameter. The measured value will be reported in millimeters.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-spleen-Spleen Thickness (millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-spleen-Splenic thickness(millimeter). Ultrasound measurement of splenic thickness. The measured value will be reported in millimeters.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-spleen-Splenic Vein Internal Diameter(millimeter)[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-spleen-Splenic Vein Internal Diameter (millimeter). Ultrasound measurement of splenic vein internal diameter. The measured value will be reported in millimeters.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-Ascites Volume-The number of participants with Ascites none, mild, moderate, or large volume[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-Ascites Volume-Ultrasound assessment for free intraperitoneal fluid (ascites). Ascites will be categorized as none, mild, moderate, or large volume. The number of participants in each category will be reported.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-both kidneys-Renal cortical thickness(millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- both kidneys-Renal cortical thickness (millimeter). Ultrasound measurement of renal cortical thickness. Measurements will be recorded and reported in millimeters.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-both kidneys--Renal Pelvic Dilation Diameter(millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- both kidneys-Renal Pelvic Dilation Diameter (millimeter). Ultrasound measurement of renal pelvic dilation diameter. Measurements will be reported in millimeters.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-both kidneys--renal cyst -The number of participants with the presence or absence of renal cysts. [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- both kidneys-presence or absence of renal cysts. Ultrasound assessment for the presence or absence of renal cysts. The number of participants in each category will be reported. Among participants with renal cysts, cyst size will be measured in millimeters and summarized
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-both kidneys-Size of Renal Cyst (millimeter). (For participants with identified renal cysts). [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- both kidneys-Size of Renal Cyst (millimeter)For participants with identified renal cysts, cyst size will be recorded in millimeters. This field will be left blank for participants without renal cysts.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-both kidneys-Renal Stone -The number of participants with the presence or absence of -Renal Stone. [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- both kidneys-Renal Stone.Ultrasound assessment for the presence or absence of renal stones. The number of participants in each category will be reported. Among participants with renal stones, stone size will be measured in millimeters and summarized.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-both kidneys-Size of Renal Stone (millimeter). (For participants with identified Renal Stone). [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- both kidneys-Size of Renal Stone (millimeter).For participants with identified renal stones, stone size will be recorded in millimeters. This field will be left blank for participants without renal stones.
Measured: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
FibroScan-Liver stiffness value (LSM, unit: kPa)[Safety and Tolerability Evaluation Endpoints]
FibroScan-Liver stiffness value (LSM, unit: kPa): The specific liver stiffness number and its range, used to assess the degree of liver fibrosis. Results from FibroScan or FibroTouch are acceptable. Study sites not equipped with a FibroScan or FibroTouch transient elastography device may use two-dimensional shear wave elastography (2D-SWE) to measure liver stiffness modulus in patients.
Measured: For single-dose administration, FibroScan examinations were performed during the screening phase. For multiple-dose administration, FibroScan examinations were performed during the screening phase,and then on Day337.
FibroScan-Controlled Attenuation Parameter (CAP, unit: dB/m) [Safety and Tolerability Evaluation Endpoints]
FibroScan-Controlled Attenuation Parameter (CAP, unit: dB/m). The specific CAP data and its range are used to assess the degree of liver fat changes. Results from FibroScan or FibroTouch are acceptable. Study sites not equipped with a FibroScan or FibroTouch transient elastography device may use two-dimensional shear wave elastography (2D-SWE) to measure liver stiffness modulus in patients.
Measured: For single-dose administration, FibroScan examinations were performed during the screening phase. For multiple-dose administration, FibroScan examinations were performed during the screening phase,and then on Day337.
injection site monitoring-Pain-Assessment of injection site monitoring-Pain graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
injection site monitoring-Pain-(No/Slight/Marked interference with activities of daily living). Assessment of injection site monitoring-Pain graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Measured: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring- Induration-Assessment of injection site monitoring-Induration graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
injection site monitoring- Induration(2.5-<5 cm in diameter AND no interference with activities of daily living/5-<10 cm in diameter OR slight interference with activities of daily living/≥10 cm in diameter, OR ulceration/secondary infection/phlebitis/sterile abscess/drainage from wound, OR marked interference with activities of daily living/Abscess, exfoliative dermatitis, dermal or deep tissue necrosis ). Assessment of injection site monitoring-Induration graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Measured: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-swelling-Assessment of injection site monitoring-swelling graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
injection site monitoring--swelling (2.5-<5 cm in diameter AND no interference with activities of daily living/5-<10 cm in diameter OR slight interference with activities of daily living/≥10 cm in diameter, OR ulceration/secondary infection/phlebitis/sterile abscess/drainage from wound, OR marked interference with activities of daily living/Abscess, exfoliative dermatitis, dermal or deep tissue necrosis ). Assessment of injection site monitoring-swelling graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Measured: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Rash (erythema) -Assessment of injection site monitoring-Rash (erythema) graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
injection site monitoring-Rash (erythema) (2.5-<5 cm in diameter AND no interference with activities of daily living/5-<10 cm in diameter OR slight interference with activities of daily living/≥10 cm in diameter, OR ulceration/secondary infection/phlebitis/sterile abscess/drainage from wound, OR marked interference with activities of daily living/Abscess, exfoliative dermatitis, dermal or deep tissue necrosis ). Assessment of injection site monitoring-Rash (erythema) graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Measured: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Pruritus (at the injection site)-Assessment of injection site monitoring-Pruritus (at the injection site) graded using CTCAE Version 6.0. The number of participants in each category [Safety and Tolerability Evaluation Endpoints]
injection site monitoring-Pruritus (at the injection site)-(No/Slight/Marked interference with activities of daily living). Assessment of injection site monitoring-Pruritus (at the injection site) graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Measured: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Phlegmon -Assessment of injection site monitoring-Phlegmon graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
injection site monitoring-Phlegmon -(Requires non-parenteral therapy (e.g., oral antibacterial, antifungal, antiviral treatment) OR requires other invasive procedures/Requires intravenous therapy (e.g., intravenous antibacterial, antifungal, antiviral treatment)/ Sepsis, or tissue necrosis, etc.). Assessment of injection site monitoring-Phlegmon graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Measured: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.

Secondary outcomes (32)

Primary pharmacokinetic parameters (After a single/dose administration)-peak concentration (Cmax) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-peak concentration (Cmax)
Measured: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-time to reach peak concentration (Tmax) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-time to reach peak concentration (Tmax)
Measured: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve from time 0 to the last measurable concentration time point （AUC0-t） [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve from time 0 to the last measurable concentration time point （AUC0-t）
Measured: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve extrapolated from time 0 to infinity （AUC0-∞）[Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve extrapolated from time 0 to infinity （AUC0-∞）
Measured: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration) elimination rate constant (λz) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration) elimination rate constant (λz)
Measured: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-elimination half-life（t1/2）[Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-elimination half-life（t1/2）
Measured: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-apparent clearance (CL/F) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-apparent clearance (CL/F)
Measured: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-apparent volume of distribution（Vz/F）[Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-apparent volume of distribution（Vz/F）
Measured: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-mean residence time（MRT0-t、MRT0-∞）[Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-mean residence time（MRT0-t、MRT0-∞）
Measured: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-percentage of residual area (AUC_%Extrap) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-percentage of residual area (AUC_%Extrap)
Measured: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state peak concentration(Cmax,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- steady-state peak concentration(Cmax,ss)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state trough concentration (Cmin,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- steady-state trough concentration (Cmin,ss)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- mean steady-state plasma concentration (Cav,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- mean steady-state plasma concentration (Cav,ss)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state time to peak concentration ( Tmax,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- steady-state time to peak concentration ( Tmax,ss)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- area under the plasma concentration-time curve from time 0 after the last dose to the last measurable concentration time point (AUC0-t,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- area under the plasma concentration-time curve from time 0 after the last dose to the last measurable concentration time point (AUC0-t,ss)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)-area under the plasma concentration-time curve extrapolated from time 0 after the last dose to infinity ( AUC0-∞,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)-area under the plasma concentration-time curve extrapolated from time 0 after the last dose to infinity ( AUC0-∞,ss)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- elimination rate constant (λz) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- elimination rate constant (λz)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- elimination half-life (t1/2,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- elimination half-life (t1/2,ss)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent clearance (CLss/F) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent clearance (CLss/F)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent volume of distribution ( Vz,ss/F) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent volume of distribution ( Vz,ss/F)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- mean residence time (MRT0-∞) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- mean residence time (MRT0-∞)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- fluctuation coefficient (DF) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- fluctuation coefficient (DF)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- accumulation index (Rac,AUC、Rac,Cmax) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- accumulation index (Rac,AUC、Rac,Cmax)
Measured: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary PD endpoints-quantitative HBsAg [Pharmacodynamic (efficacy) Evaluation Indicators]
Primary PD endpoints-quantitative HBsAg
Measured: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints-quantitative HBsAb [Pharmacodynamic (efficacy) Evaluation Indicators]
Primary PD endpoints-quantitative HBsAb
Measured: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative anti-Pre-S1 [Pharmacodynamic (efficacy) Evaluation Indicators]
Primary PD endpoints--quantitative anti-Pre-S1
Measured: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative hepatitis B e antigen (HBeAg) [Pharmacodynamic (efficacy) Evaluation Indicators]
Primary PD endpoints--quantitative hepatitis B e antigen (HBeAg)
Measured: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative hepatitis B e antibody (HBeAb)[Pharmacodynamic (efficacy) Evaluation Indicators]
Primary PD endpoints--quantitative hepatitis B e antibody (HBeAb)
Measured: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative hepatitis B core antibody (HBcAb) [Pharmacodynamic (efficacy) Evaluation Indicators]
Primary PD endpoints--quantitative hepatitis B core antibody (HBcAb)
Measured: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Secondary PD endpoints-HBV DNA quantification [Pharmacodynamic (efficacy) Evaluation Indicators]
Secondary PD endpoints-HBV DNA quantification
Measured: Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.
Secondary PD endpoints-HBV RNA quantification [Pharmacodynamic (efficacy) Evaluation Indicators]
Secondary PD endpoints-HBV RNA quantification
Measured: Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.
Secondary PD endpoints-hepatitis B core antigen (HBcrAg) quantification [Pharmacodynamic (efficacy) Evaluation Indicators]
Secondary PD endpoints-hepatitis B core antigen (HBcrAg) quantification
Measured: Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 20263 Jul 2028

First posted5 Nov 2026
Study start3 Jul 2026
Primary completion4 Mar 2027 (estimated)
Study completion3 Jul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 74 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07918456
Sponsor's protocol ID: CPU-YL01-101
Status last verified: Oct 2026
First submitted: 15 Sep 2026
Last updated: 5 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Chu L, McPhee R, Huang W, Bennett H, Pajon R, Nestorova B, Leav B; mRNA-1273 Study Group. A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine. 2021 May 12;39(20):2791-2799. doi: 10.1016/j.vaccine.2021.02.007. Epub 2021 Feb 9.
PubMed 33707061
Shaw CA, Essink B, Harper C, Mithani R, Kapoor A, Dhar R, Wilson L, Guo R, Panozzo CA, Wilson E, Simorellis AK, Reuter C, Stoszek SK, Chen GL, Das R, Goswami J. Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults. J Infect Dis. 2024 Sep 23;230(3):e647-e656. doi: 10.1093/infdis/jiae081.
PubMed 38385566
Tak WY, Chuang WL, Chen CY, Tseng KC, Lim YS, Lo GH, Heo J, Agarwal K, Bussey L, Teoh SL, Tria A, Brown A, Anderson K, Vardeu A, O'Brien S, Kopycinski J, Kolenovska R, Barnes E, Evans T. Phase Ib/IIa randomized study of heterologous ChAdOx1-HBV/MVA-HBV therapeutic vaccination (VTP-300) as monotherapy and combined with low-dose nivolumab in virally-suppressed patients with CHB. J Hepatol. 2024 Dec;81(6):949-959. doi: 10.1016/j.jhep.2024.06.027. Epub 2024 Jul 6.
PubMed 38972484
Fleites YA, Aguiar J, Cinza Z, Bequet M, Marrero E, Vizcaino M, Esquivel I, Diaz M, Sin-Mayor A, Garcia M, Martinez SM, Beato A, Galarraga AG, Mendoza-Mari Y, Valdes I, Garcia G, Lemos G, Gonzalez I, Canaan-Haden C, Figueroa N, Oquendo R, Akbar SM, Mahtab MA, Uddin MH, Guillen GE, Muzio VL, Penton E, Aguilar JC. HeberNasvac, a Therapeutic Vaccine for Chronic Hepatitis B, Stimulates Local and Systemic Markers of Innate Immunity: Potential Use in SARS-CoV-2 Postexposure Prophylaxis. Euroasian J Hepatogastroenterol. 2021 Jul-Dec;11(2):59-70. doi: 10.5005/jp-journals-10018-1344.
PubMed 34786358
Akbar SM, Yoshida O, Chen S, Cesar AJ, Abe M, Matsuura B, Hiasa Y, Onji M. Immune modulator and antiviral potential of dendritic cells pulsed with both hepatitis B surface antigen and core antigen for treating chronic HBV infection. Antivir Ther. 2010;15(6):887-95. doi: 10.3851/IMP1637.
PubMed 20834101
Cargill T, Cicconi P, Brown A, Holland L, Karanth B, Rutkowski K, Ashwin E, Mehta R, Chinnakannan S, Sebastian S, Bussey L, Sorensen H, Klenerman P, Evans T, Barnes E. HBV001: Phase I study evaluating the safety and immunogenicity of the therapeutic vaccine ChAdOx1-HBV. JHEP Rep. 2023 Aug 18;5(11):100885. doi: 10.1016/j.jhepr.2023.100885. eCollection 2023 Nov.
PubMed 37791379
Ma H, Lim TH, Leerapun A, Weltman M, Jia J, Lim YS, Tangkijvanich P, Sukeepaisarnjaroen W, Ji Y, Le Bert N, Li D, Zhang Y, Hamatake R, Tan N, Li C, Strasser SI, Ding H, Yoon JH, Stace NH, Ahmed T, Anderson DE, Yan L, Bertoletti A, Zhu Q, Yuen MF. Therapeutic vaccine BRII-179 restores HBV-specific immune responses in patients with chronic HBV in a phase Ib/IIa study. JHEP Rep. 2021 Sep 8;3(6):100361. doi: 10.1016/j.jhepr.2021.100361. eCollection 2021 Dec.
PubMed 34661089

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection

All Chronic Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Trial to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of CPU-YL01 Injection in Patients With Chronic Hepatitis B
ClinicalTrials.gov ID: NCT07918456
Acronym / sponsor ID: CPU-YL01-101
Conditions: Chronic Hepatitis B
Phase: Phase 1
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 74 participants (estimated)
Lead sponsor: Jiangsu Chuangyuan Life Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 3 Jul 2026 (actual)
Primary completion: 4 Mar 2027 (estimated)
Study completion: 3 Jul 2028 (estimated)
First posted: 5 Nov 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CPU-YL01 Injection	Experimental	Drug: CPU-YL01 Injection Intramuscular administrationIntramuscular administration
Placbo Injection	Placebo comparator	Drug: Placebo intramuscular injectionIntramuscular administration

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Voluntarily sign the informed consent form (ICF), understand this study, and be willing and able to comply with and complete all trial procedures;
Open to all genders; age range: 18-70 years(inclusive);
The body mass index (BMI) ranges from 18 to 30 kg/m2(including the boundary values);
Clinically diagnosed chronic hepatitis B (serum HBsAg positivity for ≥6 months; outpatient medical records, inpatient medical records, or laboratory test results may serve as evidence);
During the screening phase, the HBsAg test result was ≤10,000 IU/mL (for participants in single-dose studies); or the HBsAg test result was ≤3,000 IU/mL (for participants in multiple-dose studies);

Key exclusion criteria (27 listed)

A history of liver cirrhosis (confirmed by liver biopsy), or the presence of complications such as gastroesophageal variceal bleeding, hepatic encephalopathy, or ascites, or a liver stiffness measurement>12.4 kPa during screening;
Presence of other clinically significant liver diseases other than chronic hepatitis B, such as autoimmune hepatitis, toxic hepatitis, hemochromatosis, alcoholic liver disease, drug-induced hepatitis, α1-antitrypsin deficiency, Wilson's disease, etc.;
Use of immunosuppressants or immunomodulators (e.g., thymus) within 6 months prior to the first dose Patients taking peptides or cytotoxic agents, or those who have received corticosteroid therapy (excluding topical, inhalational, or ophthalmic treatments) for at least one week within 6 months prior to the first dose, or those who have had a history of vaccination within 1 month prior to screening or have planned to receive vaccinations during the trial period;
Prior to the first dose, the subject has received interferon or peginterferon therapy within the preceding 6 months, or plans to receive interferon or peginterferon therapy during the trial period;
Positive for hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies, or positive for Treponema pallidum (TP) antibodies with confirmatory positive results on the rapid plasma reagin (RPR) test;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CPU-YL01 Injection Intramuscular administrationSingle-dose study：Each dose group received a single dose of treatment; on day Day1, subjects in all groups received either the test drug CPU-YL01 or a placebo via intramuscular injection. Tolerance evaluation assessments were conducted on days Day2, Day3, Day8, Day15, Day22, and Day29, respectively. Multiple-dose study：Each dose group received six administrations, with one administration every 4 weeks, specifically via intramuscular injection of the test drug CPU-YL01 or placebo on days Day1, Day29, Day57, Day85, Day113, and Day141. Tolerance evaluation assessments were conducted before administration on days Day2, Day3, Day8, and Day29; before administration on days Day36, Day57, Day85, Day113, and Day141; and on days Day142, Day143, Day148, Day169, Day225, Day281, and Day337.	Drug	CPU-YL01 Injection
Placebo intramuscular injectionSingle-dose study：Each dose group received a single dose of treatment; on day Day1, subjects in all groups received either the test drug CPU-YL01 or a placebo via intramuscular injection. Tolerance evaluation assessments were conducted on days Day2, Day3, Day8, Day15, Day22, and Day29, respectively. Multiple-dose study：Each dose group received six administrations, with one administration every 4 weeks, specifically via intramuscular injection of the test drug CPU-YL01 or placebo on days Day1, Day29, Day57, Day85, Day113, and Day141. Tolerance evaluation assessments were conducted before administration on days Day2, Day3, Day8, and Day29; before administration on days Day36, Day57, Day85, Day113, and Day141; and on days Day142, Day143, Day148, Day169, Day225, Day281, and Day337.	Drug	Placbo Injection

Primary outcome

adverse events [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
adverse events
serious adverse events [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
serious adverse events
adverse events of particular concern (AESI) [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
adverse events of particular concern (AESI)
vital signs-Blood Pressure (mmHg) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose:Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-Blood Pressure (mmHg)
vital signs-respiratory rate (breaths/min) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-respiratory rate (breaths/min)
vital signs-body temperature (°C) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-body temperature (°C)
vital signs-pulse rate (beats/min) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-pulse rate (beats/min)
physical examination- skin- Color abnormalities-jaundice -The number of participants with or without skin Color abnormalities- jaundice [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Color abnormalities: jaundice. The number of participants with or without skin Color abnormalities: jaundice will be reported by category.
physical examination- skin- Color abnormalities-pallor- The number of participants with or without skin Color abnormalities: pallor [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin- Color abnormalities: pallor. The number of participants with or without skin Color abnormalities: pallor will be reported by category.
physical examination- skin-Color abnormalities-pigmentation- The number of participants with or without skin Color abnormalities:pigmentation [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Color abnormalities : pigmentation. The number of participants with or without skin Color abnormalities:pigmentation will be reported by category.
physical examination- skin-Morphological abnormalities- rash-The number of participants with or without -Morphological abnormalities: rash [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities: rash . The number of participants with or without -Morphological abnormalities: rash will be reported by category.
physical examination- skin-Morphological abnormalities-erythema at injection site -The number of participants with or without -Morphological abnormalities: erythema at injection site [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities: erythema at injection site. The number of participants with or without -Morphological abnormalities: erythema at injection site will be reported by category.
physical examination- skin-Morphological abnormalities: induration at injection site- The number of participants with or without -Morphological abnormalities: induration at injection site [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities: induration at injection site. The number of participants with or without -Morphological abnormalities: induration at injection site will be reported by category.
physical examination-mucous membranes-Ocular conjunctiva: assessment for scleral icterus- The number of participants with or without -Ocular conjunctiva-scleral icterus [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes- Ocular conjunctiva: assessment for scleral icterus. The number of participants with or without -Ocular conjunctiva-scleral icterus will be reported by category.
physical examination-mucous membranes- Ocular conjunctiva: assessment for conjunctival pallor-The number of participants with or without -Ocular conjunctiva-conjunctival pallor [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Ocular conjunctiva: assessment for conjunctival pallor. The number of participants with or without -Ocular conjunctiva-conjunctival pallor will be reported by category.
physical examination-mucous membranes-Oral mucosa: assessment for petechiae-The number of participants with or without Oral mucosa-petechiae [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Oral mucosa: assessment for petechiae. The number of participants with or without Oral mucosa-petechiae will be reported by category.
physical examination-mucous membranes-Oral mucosa: assessment for ulceration-The number of participants with or without Oral mucosa-ulceration [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Oral mucosa: assessment for ulceration. The number of participants with or without Oral mucosa-ulceration will be reported by category.
physical examination-mucous membranes- Oral mucosa: assessment for fungal infection-The number of participants with or without Oral mucosa-fungal infection [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Oral mucosa: assessment for fungal infection. The number of participants with or without Oral mucosa-fungal infection will be reported by category.
physical examination-lymph nodes- lymph nodes enlargement -The number of participants with or without lymph nodes enlargement [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes enlargement. The number of participants with or without lymph nodes enlargement will be reported by category. (Among participants with enlarged lymph nodes, findings for lymph node consistency, mobility and tenderness will also be summarized.)
physical examination-lymph nodes- Lymph Node Consistency(Participants with Enlarged Lymph Nodes)- The number of participants with lymph node consistency- soft, firm, hard. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes- Assessment of lymph node consistency (soft, firm, hard). Among participants with enlarged lymph nodes, lymph node consistency will be assessed (soft, firm, hard). The number of participants in each consistency category will be reported.
physical examination-lymph nodes-assessment for lymph nodes mobility (Participants with Enlarged Lymph Nodes) -The number of participants with lymph node mobility -mobile, fixed. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes - Assessment of lymph node mobility (mobile / fixed). Among participants with enlarged lymph nodes, lymph node mobility will be assessed (mobile, fixed). The number of participants in each mobility category will be reported.
physical examination-lymph nodes-assessment for tenderness (Participants with Enlarged Lymph Nodes) -The number of participants with lymph node tenderness tender, non-tender. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes -assessment for tenderness. Among participants with enlarged lymph nodes, assessment for lymph node tenderness (tender, non-tender). The number of participants in each tenderness category will be reported.
physical examination-head-Face: assessment for dull facies-The number of participants with dull facies [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Face: assessment for dull facies. The number of participants with dull facies will be reported.
physical examination-head-Face: assessment for facial edema-The number of participants with facial edema [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Face: assessment for facial edema. The number of participants with facial edema will be reported.
physical examination-head-Eyes: assessment for eyelid edema-The number of participants with eyelid edema [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Eyes: assessment for eyelid edema. The number of participants with eyelid edema will be reported.
physical examination-head-Eyes: assessment for pupillary light reflex-The number of participants with normal, abnormal pupillary light reflex [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Eyes: assessment for pupillary light reflex. Assessment of pupillary light reflex (normal / abnormal). The number of participants with normal, abnormal pupillary light reflex will be reported.
physical examination-head-assessment for alopecia- The number of participants with alopecia [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-assessment for alopecia. The number of participants with alopecia will be reported.
physical examination-neck-assessment for Thyroid Enlargement- The number of participants with Thyroid Enlargement [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for Thyroid Enlargement. The number of participants with Thyroid Enlargement will be reported.
physical examination-neck-assessment for Thyroid nodules-The number of participants with Thyroid nodules [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for Thyroid nodules. The number of participants with Thyroid nodules will be reported.
physical examination-neck-assessment of tracheal position-The number of participants with tracheal position midline / deviated [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment of tracheal position (midline / deviated). The number of participants in each category will be reported.
physical examination-neck-assessment for nuchal rigidity-The number of participants with nuchal rigidity [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for nuchal rigidity. The number of participants with nuchal rigidity will be reported.
physical examination- chest-Lungs: assessment of breath sound clarity-The number of participants with lung breath sounds clear, wheezes, rales. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Lungs: Assessment of lung breath sounds (clear, wheezes, rales). The number of participants in each category will be reported.
physical examination- chest-Heart: assessment of cardiac rhythm regularity-The number of participants with cardiac rhythm regular, irregular. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Heart: Assessment of cardiac rhythm (regular / irregular). The number of participants in each category will be reported.
physical examination- chest-Heart: assessment of cardiac murmur-The number of participants with cardiac murmur present, absent. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Heart: Assessment for cardiac murmur (present / absent). The number of participants in each category will be reported.
physical examination-abdomen-Liver: assessment of Palpability of Liver Edge Below Right Midclavicular Costal Margin-The number of participants with the liver edge palpable, not palpable. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver. Abdominal palpation to assess whether the liver edge is palpable below the right midclavicular costal margin (palpable / not palpable). The number of participants in each category will be reported.
physical examination-abdomen-Liver: Distance of Palpable Liver Edge Below the Right Midclavicular Costal Margin (centimeter)(For participants with a palpable liver edge)[Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver-Distance of Palpable Liver Edge Below the Right Midclavicular Costal Margin (centimeter). For participants with a palpable liver edge below the right midclavicular costal margin, the subcostal distance will be measured and reported in centimeters. This field will be left blank for participants without a palpable liver edge.
physical examination-abdomen-Liver: assessment of hepatic consistency-The number of participants with hepatic consistency soft, firm, hard.(For participants with a palpable liver edge) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver: assessment of consistency (soft, firm, hard). Among participants with a palpable liver edge below the costal margin, hepatic consistency is assessed (soft, firm, hard). The number of participants in each consistency category will be reported.
physical examination-abdomen-assessment for abdominal wall varices-The number of participants with abdominal wall varices [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for abdominal wall varices.The number of participants with abdominal wall varices will be reported.
physical examination-abdomen-assessment for abdominal tenderness-The number of participants with abdominal tenderness [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for abdominal tenderness.The number of participants with abdominal tenderness will be reported.
physical examination-abdomen-assessment for rebound tenderness-The number of participants with rebound tenderness. [Safety and Tolerability Evaluation Endpoints
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for rebound tenderness. The number of participants with rebound tenderness will be reported.
physical examination-abdomen-assessment for shifting dullness (indicative of ascites)-The number of participants-shifting dullness for ascites screening positive, negative. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Percussion assessment for shifting dullness for ascites screening (positive / negative). The number of participants in each category will be reported.
physical examination-abdomen-Spleen: assessment of Palpability of Spleen Edge Below Left Midclavicular Costal Margin-The number of participants with the splenic edge palpable, not palpable. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Spleen-Abdominal palpation to assess whether the splenic edge is palpable below the left midclavicular costal margin (palpable / not palpable). The number of participants in each category will be reported.
physical examination-abdomen-Spleen: Distance of Palpable Spleen Edge Below the Left Midclavicular Costal Margin (centimeter)(For participants with a palpable splenic edge ) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Spleen- Distance of Palpable Spleen Edge Below the Left Midclavicular Costal Margin (centimeter) .For participants with a palpable splenic edge below the left midclavicular costal margin, the subcostal distance will be measured and reported in centimeters. This field will be left blank for participants without a palpable splenic edge.
physical examination- spine/limbs-Extremities: assessment for bilateral lower extremity edema-The number of participants with bilateral lower extremity edema [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for bilateral lower extremity edema. The number of participants with bilateral lower extremity edema will be reported.
physical examination- spine/limbs-Extremities: assessment for joint erythema-The number of participants with joint erythema [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint erythema.The number of participants with joint erythema will be reported.
physical examination- spine/limbs-Extremities: assessment for joint warmth -The number of participants with joint warmth [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint warmth. The number of participants with joint warmth will be reported.
physical examination- spine/limbs-Extremities: assessment for joint tenderness -The number of participants with joint tenderness [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint tenderness. The number of participants with joint tenderness will be reported.
physical examination- spine/limbs-Extremities: assessment for joint swelling -The number of participants with joint swelling [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint swelling. The number of participants with joint swelling will be reported.
physical examination- spine/limbs-Spine: assessment for deformity The number of participants with Spine deformity. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Spine: assessment for deformity. The number of participants with Spine deformity. will be reported.
physical examination- spine/limbs-Extremities: Spine: assessment for tenderness -The number of participants withwith Spine tenderness [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint swelling. The number of participants with joint swelling will be reported.
physical examination- spine/limbs-Spine: assessment for limited range of motion The number of participants with limited range of motion . [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Spine: assessment for limited range of motion. The number of participants with limited range of motion of Spine will be reported.
physical examination--assessment of development- The number of participants with development good, fair, poor. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-assessment of development. General physical examination assessment of development (good, fair, poor).. The number of participants in each category will be reported.
physical examination--assessment of nutritional status- The number of participants with nutritional status good, fair, poor. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-assessment of nutritional status. Assessment of nutritional status (good, fair, poor). The number of participants in each category will be reported.
physical examination--assessment of mental status- The number of participants with mental status alert, drowsy, agitated, comatose. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-other areas-Assessment of mental status (alert, drowsy, agitated, comatose). The number of participants in each category will be reported.
12-lead electrocardiogram-heart rate [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-heart rate
12-lead electrocardiogram-PR interval [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-PR interval
12-lead electrocardiogram-RR interval [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-RR interval
12-lead electrocardiogram-QRS [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-QRS
12-lead electrocardiogram-QT interval [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-QT interval
12-lead electrocardiogram-QTcF [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-QTcF
12-lead electrocardiogram-electrocardiographic diagnostic results [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-electrocardiographic diagnostic results
Clinical laboratory tests-hematology-red blood cell count (RBC) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-red blood cell count (RBC)
Clinical laboratory tests-hematology-Concentration of hemoglobin (HGB) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-Concentration of hemoglobin (HGB)
Clinical laboratory tests-hematology-white blood cell count (WBC) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-white blood cell count (WBC)
Clinical laboratory tests-hematology-absolute neutrophil count (ANC) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-absolute neutrophil count (ANC)
Clinical laboratory tests-hematology-platelet count (PLT) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-platelet count (PLT)
Clinical laboratory tests-Urinalysis-Concentration of urine protein (UPRO) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-Concentration of urine protein (UPRO)
Clinical laboratory tests-Urinalysis-count of urine red blood cells (RBC) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-count of urine red blood cells (RBC)
Clinical laboratory tests-Urinalysis-count of urine white blood cells (WBC) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-count of urine white blood cells (WBC)
Clinical laboratory tests-Urinalysis-Concentration of glucose (GLU-U) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-Concentration of glucose (GLU-U)
Clinical laboratory tests-Urinalysis-Concentration of ketones (KET) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-Concentration of ketones (KET)
Clinical laboratory tests-Blood biochemistry-enzyme activity of alanine aminotransferase (ALT) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of alanine aminotransferase (ALT)
Clinical laboratory tests-Blood biochemistry-enzyme activity of aspartate aminotransferase (AST) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of aspartate aminotransferase (AST)
Clinical laboratory tests-Blood biochemistry-enzyme activity of γ-glutamyl transferase(γ-GGT) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of γ-glutamyl transferase(γ-GGT)
Clinical laboratory tests-Blood biochemistry-enzyme activity of alkaline phosphatase (ALP) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2,Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of alkaline phosphatase (ALP)
Clinical laboratory tests-Blood biochemistry-enzyme activity of cholinesterase (CHE) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of cholinesterase (CHE)
Clinical laboratory tests-Blood biochemistry-Concentration of albumin (ALB) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests- Blood biochemistry-Concentration of albumin (ALB)
Clinical laboratory tests-Blood biochemistry-Concentration of total protein (TP) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of total protein (TP)
Clinical laboratory tests-Blood biochemistry-Concentration of total bilirubin (TBil) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of total bilirubin (TBil)
Clinical laboratory tests-Blood biochemistry-Concentration of direct bilirubin (DBil) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of direct bilirubin (DBil)
Clinical laboratory tests-Blood biochemistry-Concentration of serum creatinine (Cr) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of serum creatinine (Cr)
Clinical laboratory tests-Blood biochemistry-Concentration of serum uric acid (UA) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of serum uric acid (UA)
Clinical laboratory tests-Blood biochemistry-Concentration of urea/blood urea nitrogen (Urea/BUN) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of urea/blood urea nitrogen (Urea/BUN)
Clinical laboratory tests-Blood biochemistry-Concentration of total cholesterol (TC) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of total cholesterol (TC)
Clinical laboratory tests-Blood biochemistry-Concentration of triglycerides (TG) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of triglycerides (TG)
Clinical laboratory tests-Blood biochemistry-Concentration of high-density lipoprotein cholesterol (HDL-C) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of high-density lipoprotein cholesterol (HDL-C)
Clinical laboratory tests-Blood biochemistry-Concentration of low-density lipoprotein cholesterol (LDL-C) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of low-density lipoprotein cholesterol (LDL-C)
Clinical laboratory tests-Blood biochemistry-Concentration of serum glucose (GLU) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of serum glucose (GLU)
Clinical laboratory tests-Blood biochemistry-Concentration of phosphorus ion levels [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of phosphorus ion levels
Clinical laboratory tests-Blood biochemistry-Concentration of potassium ion levels [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of potassium ion levels
Clinical laboratory tests-Blood biochemistry-Concentration of sodium ion levels [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of sodium ion levels
Clinical laboratory tests-Blood biochemistry-Concentration of chloride ion levels [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of chloride ion levels
Clinical laboratory tests-Blood biochemistry-Concentration of calcium ion levels [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of calcium ion levels
Clinical laboratory tests-Coagulation profile-prothrombin activity (PTA) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-prothrombin activity (PTA)
Clinical laboratory tests-Coagulation profile-prothrombin time (PT) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-prothrombin time (PT)
Clinical laboratory tests-Coagulation profile-Concentration of fibrinogen (FIB) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-Concentration of fibrinogen (FIB)
Clinical laboratory tests-Coagulation profile-activated partial thromboplastin time (APTT) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-activated partial thromboplastin time (APTT)
Clinical laboratory tests-Coagulation profile-thrombin time (TT) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-thrombin time (TT)
Clinical laboratory tests--Concentration of troponinI [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Concentration of troponinI
Clinical laboratory tests--Concentration of C-reactive protein (CRP) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Concentration of C-reactive protein (CRP)
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin G (IgG) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel-Concentration of immunoglobulin G (IgG)
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin A (IgA) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin A (IgA)
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C4 [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C4
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin G (IgG) [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin G (IgG)
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C3 [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C3
abdominal ultrasound- liver-Liver size(millimeter) [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Liver size (millimeter)
abdominal ultrasound- liver-Hepatic Capsule - The number of participants with hepatic capsule findings normal, abnormal.[Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Abdominal examination for hepatic capsule findings (normal / abnormal). The number of participants in each category will be reported.
abdominal ultrasound- liver-Hepatic Parenchymal echotexture - The number of participants with hepatic parenchymal echotexture normal, abnormal.[Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Parenchymal echotexture. Assessment of hepatic parenchymal echotexture (normal / abnormal). The number of participants in each category will be reported.
abdominal ultrasound- liver-Portal Vein Internal Diameter (millimeter).[Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Portal Vein Internal Diameter (millimeter)
abdominal ultrasound- liver-intrahepatic biliary duct dilation-The number of participants with intrahepatic biliary duct dilation .[Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-intrahepatic biliary duct dilation. The number of participants with intrahepatic biliary duct dilation will be reported.
abdominal ultrasound- liver-extrahepatic biliary duct dilation-The number of participants with extrahepatic biliary duct dilation .[Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-extrahepatic biliary duct dilation.The number of participants with extrahepatic biliary duct dilation will be reported.
abdominal ultrasound- liver-Hepatic Solid Space-Occupying Lesion-The number of participants with the presence or absence of hepatic solid space-occupying lesions .[Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Hepatic Solid Space-Occupying Lesion. Abdominal ultrasound assessment for the presence or absence of hepatic solid space-occupying lesions. The number of participants in each category will be reported. Among participants with identified lesions, lesion size and location will be summarized.
abdominal ultrasound- liver-Size of Hepatic Solid Space-Occupying Lesions (centimeter).( For participants with hepatic solid space-occupying lesions identified on abdominal ultrasound)[Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Size of Hepatic Solid Space-Occupying Lesions (centimeter) . Among participants with hepatic solid space-occupying lesions identified on abdominal ultrasound, lesion size will be recorded in centimeters. Lesion location will also be documented. This field will be blank for participants without hepatic solid space-occupying lesions.
abdominal ultrasound-gallbladder-Gallbladder wall Thickness(millimeter) [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-gallbladder-Gallbladder wall Thickness (millimeter)
abdominal ultrasound-gallbladder-gallstones-The number of participants with the presence or absence of gallstones[Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-gallbladder-gallstones. Ultrasound assessment for the presence or absence of gallstones. The number of participants in each category will be reported.
abdominal ultrasound-gallbladder-gallbladder polyps-The number of participants with the presence or absence of gallbladder polyps. [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-gallbladder-gallbladder polyps. Ultrasound assessment for the presence or absence of gallbladder polyps. The number of participants in each category will be reported.
abdominal ultrasound-pancreas-Pancreatic Duct Internal Diameter(millimeter) [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-pancreas-Pancreatic Duct Internal Diameter(millimeter).Ultrasound measurement of pancreatic duct internal diameter. Measurements will be recorded and reported in millimeters.
abdominal ultrasound-pancreas-Pancreatic Contour-The number of participants with pancreatic contour normal, abnormal. [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-pancreas-Pancreatic Contour. Ultrasound assessment of pancreatic contour (normal / abnormal). The number of participants in each category will be reported.
abdominal ultrasound-spleen-Spleen Longitudinal Diameter (millimeter) [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- spleen-Spleen Longitudinal Diameter (millimeter). Ultrasound measurement of splenic longitudinal diameter. The measured value will be reported in millimeters.
abdominal ultrasound-spleen-Spleen Thickness (millimeter) [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-spleen-Splenic thickness(millimeter). Ultrasound measurement of splenic thickness. The measured value will be reported in millimeters.
abdominal ultrasound-spleen-Splenic Vein Internal Diameter(millimeter)[Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-spleen-Splenic Vein Internal Diameter (millimeter). Ultrasound measurement of splenic vein internal diameter. The measured value will be reported in millimeters.
abdominal ultrasound-Ascites Volume-The number of participants with Ascites none, mild, moderate, or large volume[Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-Ascites Volume-Ultrasound assessment for free intraperitoneal fluid (ascites). Ascites will be categorized as none, mild, moderate, or large volume. The number of participants in each category will be reported.
abdominal ultrasound-both kidneys-Renal cortical thickness(millimeter) [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- both kidneys-Renal cortical thickness (millimeter). Ultrasound measurement of renal cortical thickness. Measurements will be recorded and reported in millimeters.
abdominal ultrasound-both kidneys--Renal Pelvic Dilation Diameter(millimeter) [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- both kidneys-Renal Pelvic Dilation Diameter (millimeter). Ultrasound measurement of renal pelvic dilation diameter. Measurements will be reported in millimeters.
abdominal ultrasound-both kidneys--renal cyst -The number of participants with the presence or absence of renal cysts. [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- both kidneys-presence or absence of renal cysts. Ultrasound assessment for the presence or absence of renal cysts. The number of participants in each category will be reported. Among participants with renal cysts, cyst size will be measured in millimeters and summarized
abdominal ultrasound-both kidneys-Size of Renal Cyst (millimeter). (For participants with identified renal cysts). [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- both kidneys-Size of Renal Cyst (millimeter)For participants with identified renal cysts, cyst size will be recorded in millimeters. This field will be left blank for participants without renal cysts.
abdominal ultrasound-both kidneys-Renal Stone -The number of participants with the presence or absence of -Renal Stone. [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- both kidneys-Renal Stone.Ultrasound assessment for the presence or absence of renal stones. The number of participants in each category will be reported. Among participants with renal stones, stone size will be measured in millimeters and summarized.
abdominal ultrasound-both kidneys-Size of Renal Stone (millimeter). (For participants with identified Renal Stone). [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- both kidneys-Size of Renal Stone (millimeter).For participants with identified renal stones, stone size will be recorded in millimeters. This field will be left blank for participants without renal stones.
FibroScan-Liver stiffness value (LSM, unit: kPa)[Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration, FibroScan examinations were performed during the screening phase. For multiple-dose administration, FibroScan examinations were performed during the screening phase,and then on Day337.
FibroScan-Liver stiffness value (LSM, unit: kPa): The specific liver stiffness number and its range, used to assess the degree of liver fibrosis. Results from FibroScan or FibroTouch are acceptable. Study sites not equipped with a FibroScan or FibroTouch transient elastography device may use two-dimensional shear wave elastography (2D-SWE) to measure liver stiffness modulus in patients.
FibroScan-Controlled Attenuation Parameter (CAP, unit: dB/m) [Safety and Tolerability Evaluation Endpoints]
Time frame: For single-dose administration, FibroScan examinations were performed during the screening phase. For multiple-dose administration, FibroScan examinations were performed during the screening phase,and then on Day337.
FibroScan-Controlled Attenuation Parameter (CAP, unit: dB/m). The specific CAP data and its range are used to assess the degree of liver fat changes. Results from FibroScan or FibroTouch are acceptable. Study sites not equipped with a FibroScan or FibroTouch transient elastography device may use two-dimensional shear wave elastography (2D-SWE) to measure liver stiffness modulus in patients.
injection site monitoring-Pain-Assessment of injection site monitoring-Pain graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Pain-(No/Slight/Marked interference with activities of daily living). Assessment of injection site monitoring-Pain graded using CTCAE Version 6.0. The number of participants in each category will be reported.
injection site monitoring- Induration-Assessment of injection site monitoring-Induration graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring- Induration(2.5-<5 cm in diameter AND no interference with activities of daily living/5-<10 cm in diameter OR slight interference with activities of daily living/≥10 cm in diameter, OR ulceration/secondary infection/phlebitis/sterile abscess/drainage from wound, OR marked interference with activities of daily living/Abscess, exfoliative dermatitis, dermal or deep tissue necrosis ). Assessment of injection site monitoring-Induration graded using CTCAE Version 6.0. The number of participants in each category will be reported.
injection site monitoring-swelling-Assessment of injection site monitoring-swelling graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring--swelling (2.5-<5 cm in diameter AND no interference with activities of daily living/5-<10 cm in diameter OR slight interference with activities of daily living/≥10 cm in diameter, OR ulceration/secondary infection/phlebitis/sterile abscess/drainage from wound, OR marked interference with activities of daily living/Abscess, exfoliative dermatitis, dermal or deep tissue necrosis ). Assessment of injection site monitoring-swelling graded using CTCAE Version 6.0. The number of participants in each category will be reported.
injection site monitoring-Rash (erythema) -Assessment of injection site monitoring-Rash (erythema) graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Rash (erythema) (2.5-<5 cm in diameter AND no interference with activities of daily living/5-<10 cm in diameter OR slight interference with activities of daily living/≥10 cm in diameter, OR ulceration/secondary infection/phlebitis/sterile abscess/drainage from wound, OR marked interference with activities of daily living/Abscess, exfoliative dermatitis, dermal or deep tissue necrosis ). Assessment of injection site monitoring-Rash (erythema) graded using CTCAE Version 6.0. The number of participants in each category will be reported.
injection site monitoring-Pruritus (at the injection site)-Assessment of injection site monitoring-Pruritus (at the injection site) graded using CTCAE Version 6.0. The number of participants in each category [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Pruritus (at the injection site)-(No/Slight/Marked interference with activities of daily living). Assessment of injection site monitoring-Pruritus (at the injection site) graded using CTCAE Version 6.0. The number of participants in each category will be reported.
injection site monitoring-Phlegmon -Assessment of injection site monitoring-Phlegmon graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
Time frame: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Phlegmon -(Requires non-parenteral therapy (e.g., oral antibacterial, antifungal, antiviral treatment) OR requires other invasive procedures/Requires intravenous therapy (e.g., intravenous antibacterial, antifungal, antiviral treatment)/ Sepsis, or tissue necrosis, etc.). Assessment of injection site monitoring-Phlegmon graded using CTCAE Version 6.0. The number of participants in each category will be reported.

32 secondary outcomes

Primary pharmacokinetic parameters (After a single/dose administration)-peak concentration (Cmax) [Pharmacokinetic Evaluation Parameters]
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-time to reach peak concentration (Tmax) [Pharmacokinetic Evaluation Parameters]
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve from time 0 to the last measurable concentration time point （AUC0-t） [Pharmacokinetic Evaluation Parameters]
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve extrapolated from time 0 to infinity （AUC0-∞）[Pharmacokinetic Evaluation Parameters]
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration) elimination rate constant (λz) [Pharmacokinetic Evaluation Parameters]
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-elimination half-life（t1/2）[Pharmacokinetic Evaluation Parameters]
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-apparent clearance (CL/F) [Pharmacokinetic Evaluation Parameters]
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-apparent volume of distribution（Vz/F）[Pharmacokinetic Evaluation Parameters]
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-mean residence time（MRT0-t、MRT0-∞）[Pharmacokinetic Evaluation Parameters]
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-percentage of residual area (AUC_%Extrap) [Pharmacokinetic Evaluation Parameters]
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state peak concentration(Cmax,ss) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state trough concentration (Cmin,ss) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- mean steady-state plasma concentration (Cav,ss) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state time to peak concentration ( Tmax,ss) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- area under the plasma concentration-time curve from time 0 after the last dose to the last measurable concentration time point (AUC0-t,ss) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)-area under the plasma concentration-time curve extrapolated from time 0 after the last dose to infinity ( AUC0-∞,ss) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- elimination rate constant (λz) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- elimination half-life (t1/2,ss) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent clearance (CLss/F) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent volume of distribution ( Vz,ss/F) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- mean residence time (MRT0-∞) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- fluctuation coefficient (DF) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- accumulation index (Rac,AUC、Rac,Cmax) [Pharmacokinetic Evaluation Parameters]
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary PD endpoints-quantitative HBsAg [Pharmacodynamic (efficacy) Evaluation Indicators]
Time frame: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints-quantitative HBsAb [Pharmacodynamic (efficacy) Evaluation Indicators]
Time frame: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative anti-Pre-S1 [Pharmacodynamic (efficacy) Evaluation Indicators]
Time frame: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative hepatitis B e antigen (HBeAg) [Pharmacodynamic (efficacy) Evaluation Indicators]
Time frame: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative hepatitis B e antibody (HBeAb)[Pharmacodynamic (efficacy) Evaluation Indicators]
Time frame: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative hepatitis B core antibody (HBcAb) [Pharmacodynamic (efficacy) Evaluation Indicators]
Time frame: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Secondary PD endpoints-HBV DNA quantification [Pharmacodynamic (efficacy) Evaluation Indicators]
Time frame: Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.
Secondary PD endpoints-HBV RNA quantification [Pharmacodynamic (efficacy) Evaluation Indicators]
Time frame: Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.
Secondary PD endpoints-hepatitis B core antigen (HBcrAg) quantification [Pharmacodynamic (efficacy) Evaluation Indicators]
Time frame: Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Background: PubMed 33707061Chu L, McPhee R, Huang W, Bennett H, Pajon R, Nestorova B, Leav B; mRNA-1273 Study Group. A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine. 2021 May 12;39(20):2791-2799. doi: 10.1016/j.vaccine.2021.02.007. Epub 2021 Feb 9.
Background: PubMed 38385566Shaw CA, Essink B, Harper C, Mithani R, Kapoor A, Dhar R, Wilson L, Guo R, Panozzo CA, Wilson E, Simorellis AK, Reuter C, Stoszek SK, Chen GL, Das R, Goswami J. Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults. J Infect Dis. 2024 Sep 23;230(3):e647-e656. doi: 10.1093/infdis/jiae081.
Background: PubMed 38972484Tak WY, Chuang WL, Chen CY, Tseng KC, Lim YS, Lo GH, Heo J, Agarwal K, Bussey L, Teoh SL, Tria A, Brown A, Anderson K, Vardeu A, O'Brien S, Kopycinski J, Kolenovska R, Barnes E, Evans T. Phase Ib/IIa randomized study of heterologous ChAdOx1-HBV/MVA-HBV therapeutic vaccination (VTP-300) as monotherapy and combined with low-dose nivolumab in virally-suppressed patients with CHB. J Hepatol. 2024 Dec;81(6):949-959. doi: 10.1016/j.jhep.2024.06.027. Epub 2024 Jul 6.
Background: PubMed 34786358Fleites YA, Aguiar J, Cinza Z, Bequet M, Marrero E, Vizcaino M, Esquivel I, Diaz M, Sin-Mayor A, Garcia M, Martinez SM, Beato A, Galarraga AG, Mendoza-Mari Y, Valdes I, Garcia G, Lemos G, Gonzalez I, Canaan-Haden C, Figueroa N, Oquendo R, Akbar SM, Mahtab MA, Uddin MH, Guillen GE, Muzio VL, Penton E, Aguilar JC. HeberNasvac, a Therapeutic Vaccine for Chronic Hepatitis B, Stimulates Local and Systemic Markers of Innate Immunity: Potential Use in SARS-CoV-2 Postexposure Prophylaxis. Euroasian J Hepatogastroenterol. 2021 Jul-Dec;11(2):59-70. doi: 10.5005/jp-journals-10018-1344.
Background: PubMed 20834101Akbar SM, Yoshida O, Chen S, Cesar AJ, Abe M, Matsuura B, Hiasa Y, Onji M. Immune modulator and antiviral potential of dendritic cells pulsed with both hepatitis B surface antigen and core antigen for treating chronic HBV infection. Antivir Ther. 2010;15(6):887-95. doi: 10.3851/IMP1637.
Background: PubMed 37791379Cargill T, Cicconi P, Brown A, Holland L, Karanth B, Rutkowski K, Ashwin E, Mehta R, Chinnakannan S, Sebastian S, Bussey L, Sorensen H, Klenerman P, Evans T, Barnes E. HBV001: Phase I study evaluating the safety and immunogenicity of the therapeutic vaccine ChAdOx1-HBV. JHEP Rep. 2023 Aug 18;5(11):100885. doi: 10.1016/j.jhepr.2023.100885. eCollection 2023 Nov.
Background: PubMed 34661089Ma H, Lim TH, Leerapun A, Weltman M, Jia J, Lim YS, Tangkijvanich P, Sukeepaisarnjaroen W, Ji Y, Le Bert N, Li D, Zhang Y, Hamatake R, Tan N, Li C, Strasser SI, Ding H, Yoon JH, Stace NH, Ahmed T, Anderson DE, Yan L, Bertoletti A, Zhu Q, Yuen MF. Therapeutic vaccine BRII-179 restores HBV-specific immune responses in patients with chronic HBV in a phase Ib/IIa study. JHEP Rep. 2021 Sep 8;3(6):100361. doi: 10.1016/j.jhepr.2021.100361. eCollection 2021 Dec.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CPU-YL01 Injection Intramuscular administration in people with Chronic Hepatitis B, run by Jiangsu Chuangyuan Life Science and Technology Co., Ltd. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adverse events [Safety and Tolerability Evaluation Endpoints] (time frame: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.). The study lists 136 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07918456, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.