Healthy VolunteersPhase 1NCT05470829
A Multiple-dose Study in Chinese Subjects to Evaluate Safety,Tolerability,PK and PD of ZM-H1505R
A Phase 1 study testing ZM-H1505R in people with Healthy Volunteers and Hepatitis B, Chronic, run by Shanghai Zhimeng Biopharma, Inc. at 1 site in China.
Trial summary
This phase Ib study included two parts in which Part I was to evaluate the safety and bridge for PK among healthy Chinese subjects and Part II were about study among Chinese chronic hepatitis B virus-infected patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Hepatitis B, Chronic
- What is being tested?
- ZM-H1505R
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2021to 17 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to sign Inform Consent Forms before study, and fully understand the study contents, process and potential adverse reactions;
- Able to complete the study in compliance with the protocol;
- Subjects (including their partners) agreed to adopt effective contraceptive measurements from screening to 6 months after the last administration.
- Part I Proprietary:
- Male and female subjects between 18 and 50 years of age, inclusive;
- At least 50 kg for male subjects, 45 kg for female, with a Body Mass Index (BMI) between 18-28 ;
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- Normal or abnormal but of no clinical significance results for physical examination and vital signs.
- Part II Proprietary::
- Male and female subjects between 18 and 65 years of age, inclusive;
- At least 50 kg for male subjects, 45 kg for female subjects, with a Body Mass Index (BMI) between 18-35 kg/m2, inclusive, BMI = weight (kg) / height 2 (m2);
- Any proof of HBV infection more than 6 months (including outpatient/inpatient medical records, HBV DNA, HBsAg test sheets, etc.); or with IgM HBcAb negative and HBsAg positive at screening;
- No history of therapy including interferon/nucleoside or analog at screening, or discontinuation for more than 1 year from interferon therapy or more than 6 months from nucleoside analog therapy;
- HBV DNA ≥ 2×105 IU/mL for HBeAg-positive patients and HBV DNA ≥ 2×104 IU/mL for HBeAg-negative patients at screening;
- Serum ALT lower than 5×upper limit of normal at screening.
Who cannot join
- Major trauma or surgery within 3 months before screening;
- History of treatment that may interfere with drug absorption (e.g, subtotal gastrectomy);
- Blood donation or massive blood loss (> 450 mL) within 3 months prior to screening;
- Any history of allergy suspected to be due to any component of the study drug, or allergic constitution (allergy to multiple drug and food);
- A history of narcotic drugs intake or alcohol abuse ;
- Acute infection within 2 weeks before screening;
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- Suffering from serious diseases of the circulatory, respiratory, urinary, vascular, endocrine, immune, mental and nervous systems;
- History of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, heart failure of grade III or IV, or stroke within 6 months prior to screening;
- Patients with existing malignant tumors (except for skin non-melanoma, cervical intraepithelial neoplasia, thyroid tumor, breast tumor, etc. after treatment with no signs of recurrence);
- Any surgery or hospitalization anticipated during the study;
- Treatment history of immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before study administration;
- Medication history of definitely strong CYP3A4 inhibitors or inducers within 2 weeks before screening;
- Involved in any other study drug administration or clinical study of medical devices within 1 month before screening; Involved in any clinical study of HBV virus nucleocapsid inhibitors in the past;
- Any abnormality of electrocardiogram not suitable for the study judged by physician;
- Positive pregnancy test results or subject is lactating for female subjects;
- Positive test results of HCV-Ab, HCV core antigen and HCV RNA (PCR); or HIV antibody; or Treponema pallidum antibody further confirmed by rapid plasma reagin (RPR) test;
- Consumption of chocolate or any diets containing caffeine or rich in xanthine, or any alcohol-containing products within 48 h before the initial administration;
- Positive results of drug abuse tests (morphine, marijuana) or alcohol breath tests;
- Other conditions in which subjects are not suitable for the study in the opinion of investigators.
- Part I Proprietary:
- More than 5 cigarettes everyday within 1 month before the study;
- Intake of any prescription or over-the-counter (OTC) drugs, vitamin, herbs, other inappropriate diet or supplements in opinion of investigators within 7 days before screening;
- Positive HBsAg test results;
- Any clinically significant abnormalities in laboratory tests.
- Part II Proprietary :
- Estimated glomerular filtration rate (eGFR) ˂ 60 mL/min/1.73 m2 based on serum creatinine and formula for modification of diet in renal disease (MDRD) based on values at screening;
- Patients with clinically significant acute or chronic liver disease not caused by HBV infection (including but not limited to alcoholic liver disease, severe or higher non-alcoholic fatty liver disease, autoimmune liver disease, Gilbert syndrome or other hereditary liver disease, drug-induced liver disease, etc. );
- Liver cirrhosis at clinical consideration or/and liver stiffness measurements (LSM) ≥ 12.4 kPa (for patients with ALT greater than the upper limit of normal, LSM ≥ 17.5 kPa); 27) Patients with clinically significant cardiac arrhythmias; history of risk factors for Torsade de Pointes (TdP) syndrome;
- Uncontrolled hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening;
- Patients with type I diabetes, or with newly diagnosed or poorly controlled type II diabetes (HbA1c > 8.5%);
- Left ventricular ejection fraction < 50%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple-center,Randomized,Double-blind,Placebo-controlled,Multiple-dose Study Among Chinese Healthy Subjects and Chronic Hepatitis B Patients to Evaluate Safety,Tolerability,Pharmacokinetics and Preliminary Pharmacodynamics of ZM-H1505R
This phase Ib study included two parts in which Part I was to evaluate the safety and bridge for PK among healthy Chinese subjects and Part II were about study among Chinese chronic hepatitis B virus-infected patients. Study of Part II was carried out following the safety assessment and racial difference evaluation in Part I.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multiple-dose phase Ib study.
It aimed in this study to evaluate the safety and tolerability and to characterize the pharmacokinetics of ZM-H1505R among Chinese healthy subjects following single and multiple doses administration, and to assess whether there are ethnic differences in PK characteristic among Chinese and American healthy subjects. Study was also conducted to evaluate the safety and tolerability, to characterize the pharmacokinetics and to assess the preliminary pharmacodynamics of ZM-H1505R following multiple ascending dose administration among chronic hepatitis B virus-infected patients; the PK/PD model was established among adults to provide a basis for the oral doses determination in subsequent clinical studies of ZM-H1505R.
Part I: Study among healthy subjects for safety evaluation and PK bridging Based on the PK results among American healthy subjects in Phase Ia study, 75 mg (cohort 1) was selected for PK bridging. Twelve healthy subjects were enrolled, of which 8 subjects received ZM-H1505R and 4 subjects received placebo.
Part II: Study among chronic hepatitis B virus-infected patients Subjects in four cohorts (scheduled as cohort 2, 50 mg; cohort 3, 100 mg; cohort 4, 200 mg; cohort 5, 300 mg) were enrolled in sequence from 50 mg dose group (cohort 2). Dose ascending was continued when safety evaluation on Day 8 showed that the lower dose could be tolerated. Based on the results of PK and tolerability and PD, dose ascending to 300 mg dose group (cohort 5) from 200 mg dose group (cohort 4) was discontinued determined by sponsor and investigators. Ten chronic hepatitis B virus-infected patients were enrolled in each cohort to receive ZM-H1505R (n=8) or placebo (n=2).
- Conditions
- Healthy Volunteers, Hepatitis B, Chronic
- Being tested
- ZM-H1505R, ZM-H1505R Placebo
- Keywords
- Hepatitis B, Chronic, randomized, double-blind, placebo-controlled, phase Ib
- 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.
ZM-H1505RDrug
Part 1 dosage form:75mg dosage:Tablet frequency: Quaque die duration: Day1; Day 4~ Day 14
Cohort 1 of Part 2 dosage form:50mg dosage:Tablet frequency: Quaque die duration: Day 1~ Day 28
Cohort 2 of Part 2 dosage form:100mg dosage:Tablet frequency: Quaque die duration: Day 1~ Day 28
Cohort 3 of Part 2 dosage form:200mg dosage:Tablet frequency: Quaque die duration: Day 1~ Day 28
ZM-H1505R PlaceboOther
Part 1 dosage form:75mg dosage:Tablet frequency: Quaque die duration: Day1; Day 4~ Day 14
Cohort 1 of Part 2 dosage form:50mg dosage:Tablet frequency: Quaque die duration: Day 1~ Day 28
Cohort 2 of Part 2 dosage form:100mg dosage:Tablet frequency: Quaque die duration: Day 1~ Day 28
Cohort 3 of Part 2 dosage form:200mg dosage:Tablet frequency: Quaque die duration: Day 1~ Day 28
| Study group | Role | What they receive |
|---|---|---|
| Part 1 75mg ZM-H1505R or placebo | Experimental | 75 mg was selected for PK bridging.Twelve healthy subjects were enrolled,of which 8 subjects received ZM-H1505R and 4 subjects received placebo.
Subjects were administrated in the morning under fasting conditions on Day 1 and afterwards Day 4 - Day 14 once daily,i.e. after 3-day washout period and followed by 11-day consecutive administration.Safety and tolerability evaluation was performed on Day 3,Day 6,Day 10 and Day 17 after the initial administration.
Two sentinel subjects (one male and one female) were enrolled to reveived ZM-H1505R.When safety evaluation on Day 3 showed that ZM-H1505R could be tolerated by sentinel subjects,and study drug concentration of sentinel subjects after the initial administration had been analysed so that PK sampling timepoints for the remaining subjects was determined, the remaining 10 subjects were enrolled to receive ZM-H1505R or placebo at a 3:2 ratio in a randomized manner. Receives: Drug: ZM-H1505R; Other: ZM-H1505R Placebo |
| Cohort 1 of Part 2 50mg ZM-H1505R or placebo | Experimental | Subjects were enrolled in sequence from 50 mg dose group (cohort 1). Dose ascending was continued when safety evaluation on Day 8 showed that the lower dose could be tolerated.
Ten chronic hepatitis B virus-infected patients were enrolled in each cohort to receive ZM-H1505R (n=8) or placebo (n=2).
Subjects in all cohorts were administrated on Day 1 - Day 28 once daily (consecutive 28-day administration) in the morning under fasting conditions.
Two sentinel subjects were enrolled in each cohort to reveived ZM-H1505R. When safety evaluation on Day 3 showed that ZM-H1505R could be tolerated by sentinel subjects, the remaining 8 subjects including HBeAg-positive and HBeAg-negative patients at a ratio of 4:4 were enrolled to receive ZM-H1505R or placebo at a 3:1 ratio in a randomized manner. Receives: Drug: ZM-H1505R; Other: ZM-H1505R Placebo |
| Cohort 2 of Part 2 100mg ZM-H1505R or placebo | Experimental | Subjects were enrolled in sequence from 100 mg dose group (cohort 2). Dose ascending was continued when safety evaluation on Day 8 showed that the lower dose could be tolerated.
Ten chronic hepatitis B virus-infected patients were enrolled in each cohort to receive ZM-H1505R (n=8) or placebo (n=2).
Subjects in all cohorts were administrated on Day 1 - Day 28 once daily (consecutive 28-day administration) in the morning under fasting conditions.
Two sentinel subjects were enrolled in each cohort to reveived ZM-H1505R. When safety evaluation on Day 3 showed that ZM-H1505R could be tolerated by sentinel subjects, the remaining 8 subjects including HBeAg-positive and HBeAg-negative patients at a ratio of 4:4 were enrolled to receive ZM-H1505R or placebo at a 3:1 ratio in a randomized manner. Receives: Drug: ZM-H1505R; Other: ZM-H1505R Placebo |
| Cohort 3 of Part 2 200mg ZM-H1505R or placebo | Experimental | Subjects were enrolled in sequence from 200 mg dose group (cohort 3). Ten chronic hepatitis B virus-infected patients were enrolled in each cohort to receive ZM-H1505R (n=8) or placebo (n=2).
Subjects in all cohorts were administrated on Day 1 - Day 28 once daily (consecutive 28-day administration) in the morning under fasting conditions.
Two sentinel subjects were enrolled in each cohort to reveived ZM-H1505R. When safety evaluation on Day 3 showed that ZM-H1505R could be tolerated by sentinel subjects, the remaining 8 subjects including HBeAg-positive and HBeAg-negative patients at a ratio of 4:4 were enrolled to receive ZM-H1505R or placebo at a 3:1 ratio in a randomized manner. Receives: Drug: ZM-H1505R; Other: ZM-H1505R Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of ZM-H1505R among Chinese healthy subjects
12 healthy subjects with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatmen
Measured: 42 days
Pharmacokinetics indicators
PK parameters of plasma ZM-H1505R in 12 healthy subjects
Measured: 42 days
Pharmacodynamics indicators
PK parameters of plasma ZM-H1505R in 30 chronic hepatitis B virus-infected patients
Measured: 56 days
To evaluate the safety and tolerability of ZM-H1505R among chronic hepatitis B virus-infected patients
30 chronic hepatitis B virus-infected patients with Abnormal Laboratory Values and/or Adverse Events That Are
Measured: 56 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start27 May 2021
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhimeng Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junqi Niu, Principal investigator, The First Hospital of Jilin UniversityYanhua Ding, Principal investigator, The First Hospital of Jilin UniversityHongxin Piao, Principal investigator, Yanbian University Affiliated Hospital (Yanbian Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470829
- Sponsor's protocol ID
- ZM-H1505R-102
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jia H, Mai J, Wu M, Chen H, Li X, Li C, Liu J, Liu C, Hu Y, Zhu X, Jiang X, Hua B, Xia T, Liu G, Deng A, Liang B, Guo R, Lu H, Wang Z, Chen H, Zhang Z, Zhang H, Niu J, Ding Y. Safety, tolerability, pharmacokinetics, and antiviral activity of the novel core protein allosteric modulator ZM-H1505R (Canocapavir) in chronic hepatitis B patients: a randomized multiple-dose escalation trial. BMC Med. 2023 Mar 16;21(1):98. doi: 10.1186/s12916-023-02814-w.
PubMed 36927420
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-center,Randomized,Double-blind,Placebo-controlled,Multiple-dose Study Among Chinese Healthy Subjects and Chronic Hepatitis B Patients to Evaluate Safety,Tolerability,Pharmacokinetics and Preliminary Pharmacodynamics of ZM-H1505R
- ClinicalTrials.gov ID
- NCT05470829
- Acronym / sponsor ID
- ZM-H1505R-102
- Conditions
- Healthy Volunteers, Hepatitis B, Chronic
- Keywords
- Hepatitis B, Chronic, randomized, double-blind, placebo-controlled, phase Ib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Shanghai Zhimeng Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 May 2021 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 22 Jul 2022 (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.
This phase Ib study included two parts in which Part I was to evaluate the safety and bridge for PK among healthy Chinese subjects and Part II were about study among Chinese chronic hepatitis B virus-infected patients. Study of Part II was carried out following the safety assessment and racial difference evaluation in Part I.
Detailed description
This is a randomized, double-blind, placebo-controlled, multiple-dose phase Ib study.
It aimed in this study to evaluate the safety and tolerability and to characterize the pharmacokinetics of ZM-H1505R among Chinese healthy subjects following single and multiple doses administration, and to assess whether there are ethnic differences in PK characteristic among Chinese and American healthy subjects. Study was also conducted to evaluate the safety and tolerability, to characterize the pharmacokinetics and to assess the preliminary pharmacodynamics of ZM-H1505R following multiple ascending dose administration among chronic hepatitis B virus-infected patients; the PK/PD model was established among adults to provide a basis for the oral doses determination in subsequent clinical studies of ZM-H1505R.
Part I: Study among healthy subjects for safety evaluation and PK bridging Based on the PK results among American healthy subjects in Phase Ia study, 75 mg (cohort 1) was selected for PK bridging. Twelve healthy subjects were enrolled, of which 8 subjects received ZM-H1505R and 4 subjects received placebo.
Part II: Study among chronic hepatitis B virus-infected patients Subjects in four cohorts (scheduled as cohort 2, 50 mg; cohort 3, 100 mg; cohort 4, 200 mg; cohort 5, 300 mg) were enrolled in sequence from 50 mg dose group (cohort 2). Dose ascending was continued when safety evaluation on Day 8 showed that the lower dose could be tolerated. Based on the results of PK and tolerability and PD, dose ascending to 300 mg dose group (cohort 5) from 200 mg dose group (cohort 4) was discontinued determined by sponsor and investigators. Ten chronic hepatitis B virus-infected patients were enrolled in each cohort to receive ZM-H1505R (n=8) or placebo (n=2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 75mg ZM-H1505R or placebo | Experimental | Drug: ZM-H1505R, Other: ZM-H1505R Placebo75 mg was selected for PK bridging.Twelve healthy subjects were enrolled,of which 8 subjects received ZM-H1505R and 4 subjects received placebo. Subjects were administrated in the morning under fasting conditions on Day 1 and afterwards Day 4 - Day 14 once daily,i.e. after 3-day washout period and followed by 11-day consecutive administration.Safety and tolerability evaluation was performed on Day 3,Day 6,Day 10 and Day 17 after the initial administration. Two sentinel subjects (one male and one female) were enrolled to reveived ZM-H1505R.When safety evaluation on Day 3 showed that ZM-H1505R could be tolerated by sentinel subjects,and study drug concentration of sentinel subjects after the initial administration had been analysed so that PK sampling timepoints for the remaining subjects was determined, the remaining 10 subjects were enrolled to receive ZM-H1505R or placebo at a 3:2 ratio in a randomized manner. |
| Cohort 1 of Part 2 50mg ZM-H1505R or placebo | Experimental | Drug: ZM-H1505R, Other: ZM-H1505R PlaceboSubjects were enrolled in sequence from 50 mg dose group (cohort 1). Dose ascending was continued when safety evaluation on Day 8 showed that the lower dose could be tolerated. Ten chronic hepatitis B virus-infected patients were enrolled in each cohort to receive ZM-H1505R (n=8) or placebo (n=2). Subjects in all cohorts were administrated on Day 1 - Day 28 once daily (consecutive 28-day administration) in the morning under fasting conditions. Two sentinel subjects were enrolled in each cohort to reveived ZM-H1505R. When safety evaluation on Day 3 showed that ZM-H1505R could be tolerated by sentinel subjects, the remaining 8 subjects including HBeAg-positive and HBeAg-negative patients at a ratio of 4:4 were enrolled to receive ZM-H1505R or placebo at a 3:1 ratio in a randomized manner. |
| Cohort 2 of Part 2 100mg ZM-H1505R or placebo | Experimental | Drug: ZM-H1505R, Other: ZM-H1505R PlaceboSubjects were enrolled in sequence from 100 mg dose group (cohort 2). Dose ascending was continued when safety evaluation on Day 8 showed that the lower dose could be tolerated. Ten chronic hepatitis B virus-infected patients were enrolled in each cohort to receive ZM-H1505R (n=8) or placebo (n=2). Subjects in all cohorts were administrated on Day 1 - Day 28 once daily (consecutive 28-day administration) in the morning under fasting conditions. Two sentinel subjects were enrolled in each cohort to reveived ZM-H1505R. When safety evaluation on Day 3 showed that ZM-H1505R could be tolerated by sentinel subjects, the remaining 8 subjects including HBeAg-positive and HBeAg-negative patients at a ratio of 4:4 were enrolled to receive ZM-H1505R or placebo at a 3:1 ratio in a randomized manner. |
| Cohort 3 of Part 2 200mg ZM-H1505R or placebo | Experimental | Drug: ZM-H1505R, Other: ZM-H1505R PlaceboSubjects were enrolled in sequence from 200 mg dose group (cohort 3). Ten chronic hepatitis B virus-infected patients were enrolled in each cohort to receive ZM-H1505R (n=8) or placebo (n=2). Subjects in all cohorts were administrated on Day 1 - Day 28 once daily (consecutive 28-day administration) in the morning under fasting conditions. Two sentinel subjects were enrolled in each cohort to reveived ZM-H1505R. When safety evaluation on Day 3 showed that ZM-H1505R could be tolerated by sentinel subjects, the remaining 8 subjects including HBeAg-positive and HBeAg-negative patients at a ratio of 4:4 were enrolled to receive ZM-H1505R or placebo at a 3:1 ratio in a randomized manner. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Able to sign Inform Consent Forms before study, and fully understand the study contents, process and potential adverse reactions;
- Able to complete the study in compliance with the protocol;
- Subjects (including their partners) agreed to adopt effective contraceptive measurements from screening to 6 months after the last administration.
- Male and female subjects between 18 and 50 years of age, inclusive;
- At least 50 kg for male subjects, 45 kg for female, with a Body Mass Index (BMI) between 18-28 ;
Key exclusion criteria (31 listed)
- Major trauma or surgery within 3 months before screening;
- History of treatment that may interfere with drug absorption (e.g, subtotal gastrectomy);
- Blood donation or massive blood loss (> 450 mL) within 3 months prior to screening;
- Any history of allergy suspected to be due to any component of the study drug, or allergic constitution (allergy to multiple drug and food);
- A history of narcotic drugs intake or alcohol abuse ;
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 |
|---|---|---|
| ZM-H1505RPart 1 dosage form:75mg dosage:Tablet frequency: Quaque die duration: Day1; Day 4~ Day 14 Cohort 1 of Part 2 dosage form:50mg dosage:Tablet frequency: Quaque die duration: Day 1~ Day 28 Cohort 2 of Part 2 dosage form:100mg dosage:Tablet frequency: Quaque die duration: Day 1~ Day 28 Cohort 3 of Part 2 dosage form:200mg dosage:Tablet frequency: Quaque die duration: Day 1~ Day 28 | Drug | Cohort 1 of Part 2 50mg ZM-H1505R or placebo, Cohort 2 of Part 2 100mg ZM-H1505R or placebo, Cohort 3 of Part 2 200mg ZM-H1505R or placebo, Part 1 75mg ZM-H1505R or placebo |
| ZM-H1505R PlaceboPart 1 dosage form:75mg dosage:Tablet frequency: Quaque die duration: Day1; Day 4~ Day 14 Cohort 1 of Part 2 dosage form:50mg dosage:Tablet frequency: Quaque die duration: Day 1~ Day 28 Cohort 2 of Part 2 dosage form:100mg dosage:Tablet frequency: Quaque die duration: Day 1~ Day 28 Cohort 3 of Part 2 dosage form:200mg dosage:Tablet frequency: Quaque die duration: Day 1~ Day 28 | Other | Cohort 1 of Part 2 50mg ZM-H1505R or placebo, Cohort 2 of Part 2 100mg ZM-H1505R or placebo, Cohort 3 of Part 2 200mg ZM-H1505R or placebo, Part 1 75mg ZM-H1505R or placebo |
Primary outcome
To evaluate the safety and tolerability of ZM-H1505R among Chinese healthy subjects
Time frame: 42 days
12 healthy subjects with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatmen
Pharmacokinetics indicators
Time frame: 42 days
PK parameters of plasma ZM-H1505R in 12 healthy subjects
Pharmacodynamics indicators
Time frame: 56 days
PK parameters of plasma ZM-H1505R in 30 chronic hepatitis B virus-infected patients
To evaluate the safety and tolerability of ZM-H1505R among chronic hepatitis B virus-infected patients
Time frame: 56 Days
30 chronic hepatitis B virus-infected patients with Abnormal Laboratory Values and/or Adverse Events That Are
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 36927420Jia H, Mai J, Wu M, Chen H, Li X, Li C, Liu J, Liu C, Hu Y, Zhu X, Jiang X, Hua B, Xia T, Liu G, Deng A, Liang B, Guo R, Lu H, Wang Z, Chen H, Zhang Z, Zhang H, Niu J, Ding Y. Safety, tolerability, pharmacokinetics, and antiviral activity of the novel core protein allosteric modulator ZM-H1505R (Canocapavir) in chronic hepatitis B patients: a randomized multiple-dose escalation trial. BMC Med. 2023 Mar 16;21(1):98. doi: 10.1186/s12916-023-02814-w.
- 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. This study is not recruiting at the moment.
Junqi Niu principal investigator
The First Hospital of Jilin University
Yanhua Ding principal investigator
The First Hospital of Jilin University
Hongxin Piao principal investigator
Yanbian University Affiliated Hospital (Yanbian Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZM-H1505R in people with Healthy Volunteers and Hepatitis B, Chronic, run by Shanghai Zhimeng Biopharma, Inc. at 1 site 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 14 inclusion and 31 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: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the safety and tolerability of ZM-H1505R among Chinese healthy subjects (time frame: 42 days). The study lists 4 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 NCT05470829, which also lists 1 linked publication.
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 22 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.