Chronic HBV InfectionPhase 1/2NCT05019040
Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of PA1010 in HBV Patients
A Phase 1/2 study testing PA1010 in people with Chronic HBV Infection, run by Zhejiang Palo Alto Pharmaceuticals, Inc. at 4 sites in China.
Trial summary
The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of multiple ascending dose (MAD) of PA1010 tablets in Chinese adults with Chronic Hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic HBV Infection
- What is being tested?
- PA1010
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesChina
- Study dates
- 17 Sep 2021to 18 Nov 2022
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign on the informed consent form to indicate willingness to participate in this study;
- Male or female CHB patients aged between 18 and 65 (including upper and lower limits), and should meet the following requirements:
- One of the following conditions:
- records show that hepatitis B surface antigen (HBsAg) is positive and / or hepatitis B virus deoxyribonucleic acid (HBV DNA) is positive for more than 6 months;
- the serum immunoglobulin M (IgM) antibody of HBcAg is negative, and HBsAg is positive;
- HBsAg positive and / or HBV DNA positive, and liver biopsy results show chronic hepatitis B (including previous biopsy results);
Show all 18Show fewer
- Have not used nucleoside (acid) analogues within 6 months before the first administration, or have received effective, nucleoside(acid) analogues or interferon treatment, but discontinuation of the drug for more than 6 months;
- For HBeAg positive patients: HBV DNA > 2 × 105 IU/mL； For HBeAg negative patients: HBV DNA > 2 × 104 IU/mL；
- 1 × Upper limit of normal value (ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN； Serum total bile Hemoglobin ≤ 2 × ULN； Creatinine clearance (clcr) > 70 ml / min (using Cockcroft Gault formula law);
- Urine protein is negative or 1+ (it is necessary to add 24 hours of urine protein quantification when 1+. If within the normal range, selected);
- No major disease history, and the physical examination, vital signs, 12 lead electrocardiogram (ECG) and laboratory examination results are normal during the screening period , although they exceed the normal reference value range, they are judged by the investigator to be of no clinical significance;
- Subjects are forbidden to donate blood or use drugs within 30 days after the last dose;
- During the study period (from signing the informed consent to the last follow-up) and within 6 months after the last dose, sperm donation and egg donation are prohibited, and there is no possibility of pregnancy (or sexual partner pregnancy), childbirth and lactation, at least one of the following conditions is met:
- Menopausal women who have menopause for more than 12 months or undergo sterilization (such as hysterectomy, ligation of both fallopian tubes or bilateral ovariectomy);
- For premenopausal women, pregnancy tests in the screening period and baseline period are negative, and they are willing to take more than one effective contraceptive method from the screening period to 6 months after the last dose, including intrauterine device, tubal ligation, double barrier method (condom / vaginal diaphragm + spermicide) and male partner vas deferens ligation, but excluding oral contraceptives;
- Men are willing to take more than one effective contraceptive method within 6 months after the last dose, including vasectomy, double barrier method, female partner's use of contraceptives, intrauterine device or tubal ligation, etc;
- Avoid sexual life within 6 months after the last dose;
- Be able to communicate with clinical staff and comply with the requirements of this study.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from the study:
- There are any medical conditions that the investigator believes may increase the risk of subjects participating in the study (especially the history of esophageal or gastrointestinal ulcer), may interfere with the absorption, distribution, metabolism or excretion of drugs, or may weaken the compliance with the study protocol;
- Patients with liver diseases other than hepatitis B, including but not limited to patients with chronic alcoholic hepatitis, drug-induced liver injury, autoimmune liver disease, known Gilbert syndrome and other hereditary liver diseases;
- Any history or current signs of liver decompensation (ascites, hepatic encephalopathy or esophageal and gastric varices bleeding) at any time before or at the time of screening, child Pugh grade B or C;
- Those who have received solid organ or bone marrow transplantation;
- History of severe kidney disease (judged by the researcher) or current signs;
Show all 23Show fewer
- Serious bone diseases (such as osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, chondrosis) or multiple bone diseases fold;
- Liver malignant tumor or other untreated malignant tumor was diagnosed before the first administration ;
- Have received any other study drug within 90 days before the first dose;
- Those who have used other nucleosides (acids) or interferons within 6 months before the first administration;
- Before the first administration, stop the prescription drug or over-the-counter drug that other researchers believe will affect the evaluation results of this study less than 14 days or 5 half lives of the drug (whichever is longer);
- Blood donation or massive blood loss (>400 ml) within 3 months before the first administration of the study drug;
- Major surgery or trauma within 6 months before the first administration;
- Take drinks or food containing grapefruit, pomegranate, papaya, grape and carambola within 14 days before the first administration, or disagree to avoid taking any drinks or food containing grapefruit, pomegranate, papaya, grape and carambola every day during the test;
- Have taken any food or drink rich in caffeine and xanthine (coffee, tea, coke, chocolate, seafood, animal liver, etc.) within 48 hours before the first administration, or do not agree to avoid taking any food or drink rich in caffeine and xanthine (coffee, tea, coke, chocolate, seafood, animal liver, etc.) every day during the test;
- Abnormal ECG in screening or baseline period, which is judged to be clinically significant by the investigator; Or QTCF > 450 ms in screening or baseline period;
- Have a history of heart disease, including a family history of sudden death caused by cardiac causes or QT interval prolongation syndrome;
- Difficulty in venous blood collection, or known to have a history of needle fainting and blood fainting for many times;
- Clinical or laboratory evidence shows that: hepatitis C virus (HCV), hepatitis D disease (HDV) persons carrying / infected with Treponema pallidum (TP) or human immunodeficiency virus (HIV);
- Known to have a history of allergy to the study drug and its excipients;
- Any history of drug abuse or urine drug test (+) during screening period;
- Have a regular drinking history within 6 months before screening. Women have more than 7 cups / week, men have more than 14 cups / week (1 cup =5 ounces of wine or 12 ounces of beer or 1.5 ounces of spirits) or the alcohol test exceeds the standard during the screening period;
- Smokers (smoking 10 or more cigarettes a day).
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Tsinghua Changgung Hospital affiliated to Tsinghua
Beijing, Beijing Municipality
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Southern Hospital of Southern Medical University
Guangzhou, Guangdong
The First Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang
About this study
Official title: A Phase 1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Multiple Ascending Dose (MAD) of PA1010 Tablets in Chinese Patients With Chronic Hepatitis B Infection
The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of multiple ascending dose (MAD) of PA1010 tablets in Chinese adults with Chronic Hepatitis B.
Read the detailed description
This is a multicenter, randomized, open-label, controlled, dose-escalation clinical trial, the objective is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of PA1010 tablets in Chinese patients with Chronic Hepatitis B (CHB). There are three dose groups of PA1010 ( 5 mg, 10 mg, and 20 mg) proposed to be tested sequentially in this study. A total of 36 patients with CHB, either hepatitis B e antigen (HBeAg)-positive (+) or HBeAg-negative (-), are planned to be enrolled in this study and will be stratified by HBeAg status by the ratio of 2: 1, that is, 24 of HBeAg + and 12 of HBeAg- patients. Twelve subjects in each dose group were randomly assigned in a 3: 1 ratio to receive either PA1010 tablets or or tenofovir disoproxil fumarate (TDF) tablets. All patients will be dosed for 28 consecutive days, and the dose-related safety, PK, and antiviral efficacy of PA1010 will be evaluated.
- Conditions
- Chronic HBV Infection
- Being tested
- PA1010
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA1010Drug
TDF as control
| Study group | Role | What they receive |
|---|---|---|
| PA1010 5 mg | Experimental | Twelve subjects will be randomly assigned at a 3: 1 ratio to receive either 5 mg of PA1010 tablets or 300 mg of TDF tablets, once daily for 28 days. Receives: Drug: PA1010 |
| PA1010 10 mg | Experimental | Twelve subjects will be randomly assigned at a 3: 1 ratio to receive either 10 mg of PA1010 tablets or 300 mg of TDF tablets, once daily for 28 days. Receives: Drug: PA1010 |
| PA1010 20 mg | Experimental | Twelve subjects will be randomly assigned at a 3: 1 ratio to receive either 20 mg of PA1010 tablets or 300 mg of TDF tablets, once daily for 28 days. Receives: Drug: PA1010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the change from baseline in Serum HBV DNA in patients
The primary efficacy endpoint is the change from baseline in Serum HBV DNA in patients on day 28 in all patients. The safety and tolerance are also observed in all treatment groups.
Measured: 28 days
Evaluation the rate of change from Baseline in Serum HBV DNA
Rate of change from Baseline in Serum HBV DNA
Measured: 28 days
Evaluation the change from Baseline in Serum HBsAg
Change from Baseline in Serum HBsAg
Measured: 28 days
Evaluation the change from Baseline in Serum ALT
Change from Baseline in Serum ALT
Measured: 28 days
Number of subjects experiencing adverse events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Measured: 28 days
Pharmacokinetics of single dose of PA1010-Cmax
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Maximum Observed Plasma Concentration (Cmax)
Measured: 28 days
Pharmacokinetics of single dose of PA1010-Tmax
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 28 days
Pharmacokinetics of single dose of PA1010-AUC
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Area Under the Plasma Concentration-Time Curve (AUC)
Measured: 28 days
ECG parameter-QTc interval、PR interval、QRS duration
A 12 lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QTc interval、PR interval、QRS duration
Measured: 28 days
Number of new abnormal signs with clinical significance
Physical examination records include: skin, lymph nodes, head and neck (including thyroid), nervous system examination (including but not limited to speech, cranial nerves, motor ability, tendon reflex, sensation, ataxia), chest (heart, lung), abdomen (liver, gallbladder, spleen, kidney), etc.
Measured: 28 days
Body temperature, blood pressure, pulse, respiratory rate
Vital signs body temperature, blood pressure, pulse, respiratory rate
Measured: 28 days
Secondary outcomes (4)
Pharmacokinetics of single dose of PA1010-T1/2
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Elimination Half-Life Period (T1/2）
Measured: 28 days
Pharmacokinetics of single dose of PA1010-Vz/F
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Apparent Volume of Distribution(Vz/F)
Measured: 28 days
Pharmacokinetics of single dose of PA1010-CL/F
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Apparent Clearance(CL/F)
Measured: 28 days
Pharmacokinetics of single dose of PA1010-λz
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Elimination Rate Constant(λz)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start17 Sep 2021
- Primary completion15 Nov 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HBV InfectionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Palo Alto Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lai Wei, MD, Principal investigator, Beijing Tsinghua Changgung Hospital affiliated to Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019040
- Sponsor's protocol ID
- PA1010-102
- Status last verified
- Jan 2023
- First submitted
- 17 Aug 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Multiple Ascending Dose (MAD) of PA1010 Tablets in Chinese Patients With Chronic Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT05019040
- Acronym / sponsor ID
- PA1010-102
- Conditions
- Chronic HBV Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Zhejiang Palo Alto Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 24 Aug 2021 (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.
The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of multiple ascending dose (MAD) of PA1010 tablets in Chinese adults with Chronic Hepatitis B.
Detailed description
This is a multicenter, randomized, open-label, controlled, dose-escalation clinical trial, the objective is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of PA1010 tablets in Chinese patients with Chronic Hepatitis B (CHB). There are three dose groups of PA1010 ( 5 mg, 10 mg, and 20 mg) proposed to be tested sequentially in this study. A total of 36 patients with CHB, either hepatitis B e antigen (HBeAg)-positive (+) or HBeAg-negative (-), are planned to be enrolled in this study and will be stratified by HBeAg status by the ratio of 2: 1, that is, 24 of HBeAg + and 12 of HBeAg- patients. Twelve subjects in each dose group were randomly assigned in a 3: 1 ratio to receive either PA1010 tablets or or tenofovir disoproxil fumarate (TDF) tablets. All patients will be dosed for 28 consecutive days, and the dose-related safety, PK, and antiviral efficacy of PA1010 will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PA1010 5 mg | Experimental | Drug: PA1010Twelve subjects will be randomly assigned at a 3: 1 ratio to receive either 5 mg of PA1010 tablets or 300 mg of TDF tablets, once daily for 28 days. |
| PA1010 10 mg | Experimental | Drug: PA1010Twelve subjects will be randomly assigned at a 3: 1 ratio to receive either 10 mg of PA1010 tablets or 300 mg of TDF tablets, once daily for 28 days. |
| PA1010 20 mg | Experimental | Drug: PA1010Twelve subjects will be randomly assigned at a 3: 1 ratio to receive either 20 mg of PA1010 tablets or 300 mg of TDF tablets, once daily for 28 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Sign on the informed consent form to indicate willingness to participate in this study;
- Male or female CHB patients aged between 18 and 65 (including upper and lower limits), and should meet the following requirements:
- Have not used nucleoside (acid) analogues within 6 months before the first administration, or have received effective, nucleoside(acid) analogues or interferon treatment, but discontinuation of the drug for more than 6 months;
- For HBeAg positive patients: HBV DNA > 2 × 105 IU/mL； For HBeAg negative patients: HBV DNA > 2 × 104 IU/mL；
- 1 × Upper limit of normal value (ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN； Serum total bile Hemoglobin ≤ 2 × ULN； Creatinine clearance (clcr) > 70 ml / min (using Cockcroft Gault formula law);
Key exclusion criteria (23 listed)
- Potential subjects who meet any of the following criteria will be excluded from the study:
- There are any medical conditions that the investigator believes may increase the risk of subjects participating in the study (especially the history of esophageal or gastrointestinal ulcer), may interfere with the absorption, distribution, metabolism or excretion of drugs, or may weaken the compliance with the study protocol;
- Patients with liver diseases other than hepatitis B, including but not limited to patients with chronic alcoholic hepatitis, drug-induced liver injury, autoimmune liver disease, known Gilbert syndrome and other hereditary liver diseases;
- Any history or current signs of liver decompensation (ascites, hepatic encephalopathy or esophageal and gastric varices bleeding) at any time before or at the time of screening, child Pugh grade B or C;
- Those who have received solid organ or bone marrow transplantation;
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 |
|---|---|---|
| PA1010TDF as control | Drug | PA1010 10 mg, PA1010 20 mg, PA1010 5 mg |
Primary outcome
Evaluation the change from baseline in Serum HBV DNA in patients
Time frame: 28 days
The primary efficacy endpoint is the change from baseline in Serum HBV DNA in patients on day 28 in all patients. The safety and tolerance are also observed in all treatment groups.
Evaluation the rate of change from Baseline in Serum HBV DNA
Time frame: 28 days
Rate of change from Baseline in Serum HBV DNA
Evaluation the change from Baseline in Serum HBsAg
Time frame: 28 days
Change from Baseline in Serum HBsAg
Evaluation the change from Baseline in Serum ALT
Time frame: 28 days
Change from Baseline in Serum ALT
Number of subjects experiencing adverse events (AEs)
Time frame: 28 days
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Pharmacokinetics of single dose of PA1010-Cmax
Time frame: 28 days
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Maximum Observed Plasma Concentration (Cmax)
Pharmacokinetics of single dose of PA1010-Tmax
Time frame: 28 days
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Time to Reach Maximum Observed Plasma Concentration (Tmax)
Pharmacokinetics of single dose of PA1010-AUC
Time frame: 28 days
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Area Under the Plasma Concentration-Time Curve (AUC)
ECG parameter-QTc interval、PR interval、QRS duration
Time frame: 28 days
A 12 lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QTc interval、PR interval、QRS duration
Number of new abnormal signs with clinical significance
Time frame: 28 days
Physical examination records include: skin, lymph nodes, head and neck (including thyroid), nervous system examination (including but not limited to speech, cranial nerves, motor ability, tendon reflex, sensation, ataxia), chest (heart, lung), abdomen (liver, gallbladder, spleen, kidney), etc.
Body temperature, blood pressure, pulse, respiratory rate
Time frame: 28 days
Vital signs body temperature, blood pressure, pulse, respiratory rate
4 secondary outcomes
Pharmacokinetics of single dose of PA1010-T1/2
Time frame: 28 days
Pharmacokinetics of single dose of PA1010-Vz/F
Time frame: 28 days
Pharmacokinetics of single dose of PA1010-CL/F
Time frame: 28 days
Pharmacokinetics of single dose of PA1010-λz
Time frame: 28 days
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 31 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Chronic HBV Infection
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
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
Lai Wei, MD principal investigator
Beijing Tsinghua Changgung Hospital affiliated to Tsinghua University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PA1010 in people with Chronic HBV Infection, run by Zhejiang Palo Alto Pharmaceuticals, Inc. 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 18 inclusion and 23 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 31 Jan 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluation the change from baseline in Serum HBV DNA in patients (time frame: 28 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2023.