Chronic Hepatitis BPhase 1NCT05414981
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
A Phase 1 study testing ABI-H3733 in people with Chronic Hepatitis B, run by Assembly Biosciences at 9 sites in 6 countries.
Trial summary
This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ABI-H3733
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 7 Aug 2022to 24 Apr 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥ 18.0 and < 35.0 kg/m(2), where BMI = weight (kg)/(height [m])(2) with a minimum body weight of 45 kg.
- Chronic hepatitis B infection, defined as HBV infection for ≥6 months documented
- Treatment-naïve or off-antiviral therapy for ≥24 weeks prior to Screening
- Lack of bridging fibrosis or cirrhosis
Who cannot join
- Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV)
- History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation
- Clinically significant diseases or conditions
- History of hepatocellular carcinoma
- Current or prior treatment for cHBV
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Bulgaria3 sites
Diagnostic Consultative Center Aleksandrovska
Sofia, Sofia-Grad, 1431
Acibadem City Clinic Tokuda Hospital
Sofia, 1407
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, 1606
Singapore2 sites
Clinical Trials and Research Centre, Singapore General Hospital
Singapore, 168753
National University Hospital
Singapore
Moldova1 site
ICS Arensia Exploratory Medicine Republican Clinical Hospital "Timofei Moșneaga"- Hospital
Chisinau, MD-2025
Romania1 site
Institute of Infectious Diseases - Hospital ARENSIA Exploratory Medicine Research Clinic National Institute of Infectious Diseases "Matei Bals"
Bucharest, 021105
About this study
Official title: A Randomized, Blinded, Placebo-Controlled, Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-H3733 or placebo.
- Conditions
- Chronic Hepatitis B
- Being tested
- ABI-H3733, Placebo
- Keywords
- cHBV, HBV, Hepatitis B
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-H3733Drug
25 mg or 100 mg tablets for oral administration
PlaceboDrug
25 mg or 100 mg tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| ABI-H3733 | Active comparator | Not described Receives: Drug: ABI-H3733 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Measured: Through end of study, up to 56 days
Secondary outcomes (9)
Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV
Measured: Through treatment period, up to 28 days
Minimum Plasma Concentration (Cmin) of ABI-H3733 in subjects with cHBV
Measured: Through treatment period, up to 28 days
Area Under Plasma Concentration-Time Curve (AUC) of ABI-H3733 in subjects with cHBV
Measured: Through treatment period, up to 28 days
Time to Maximum Plasma Concentration (Tmax) of ABI-H3733 in subjects with cHBV
Measured: Through treatment period, up to 28 days
Elimination half-life (t1/2) of ABI-H3733 in subjects with cHBV
Measured: Through treatment period, up to 28 days
To evaluate the effect of food on Cmax of ABI-H3733 in subjects with cHBV
Measured: Through treatment period, up to 28 days
To evaluate the effect of food on AUC of ABI-H3733 in subjects with cHBV
Measured: Through treatment period, up to 28 days
To evaluate the effect of food on the proportion of subjects with AEs, premature discontinuation due to AEs and abnormal laboratory results
Measured: Through treatment period, up to 28 days
To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV by Quantitative PCR
Measured: Through treatment period, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start7 Aug 2022
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414981
- Sponsor's protocol ID
- ABI-H3733-102
- Other IDs
- 2022-000318-32
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2022
- Last updated
- 29 Jun 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 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Placebo-Controlled, Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT05414981
- Acronym / sponsor ID
- ABI-H3733-102
- Conditions
- Chronic Hepatitis B
- Keywords
- cHBV, HBV, Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 10 Jun 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 is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-H3733 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABI-H3733 | Active comparator | Drug: ABI-H3733 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) ≥ 18.0 and < 35.0 kg/m(2), where BMI = weight (kg)/(height [m])(2) with a minimum body weight of 45 kg.
- Chronic hepatitis B infection, defined as HBV infection for ≥6 months documented
- Treatment-naïve or off-antiviral therapy for ≥24 weeks prior to Screening
- Lack of bridging fibrosis or cirrhosis
Key exclusion criteria (5 listed)
- Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV)
- History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation
- Clinically significant diseases or conditions
- History of hepatocellular carcinoma
- Current or prior treatment for cHBV
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 |
|---|---|---|
| ABI-H373325 mg or 100 mg tablets for oral administration | Drug | ABI-H3733 |
| Placebo25 mg or 100 mg tablets for oral administration | Drug | Placebo |
Primary outcome
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Time frame: Through end of study, up to 56 days
9 secondary outcomes
Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV
Time frame: Through treatment period, up to 28 days
Minimum Plasma Concentration (Cmin) of ABI-H3733 in subjects with cHBV
Time frame: Through treatment period, up to 28 days
Area Under Plasma Concentration-Time Curve (AUC) of ABI-H3733 in subjects with cHBV
Time frame: Through treatment period, up to 28 days
Time to Maximum Plasma Concentration (Tmax) of ABI-H3733 in subjects with cHBV
Time frame: Through treatment period, up to 28 days
Elimination half-life (t1/2) of ABI-H3733 in subjects with cHBV
Time frame: Through treatment period, up to 28 days
To evaluate the effect of food on Cmax of ABI-H3733 in subjects with cHBV
Time frame: Through treatment period, up to 28 days
To evaluate the effect of food on AUC of ABI-H3733 in subjects with cHBV
Time frame: Through treatment period, up to 28 days
To evaluate the effect of food on the proportion of subjects with AEs, premature discontinuation due to AEs and abnormal laboratory results
Time frame: Through treatment period, up to 28 days
To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV by Quantitative PCR
Time frame: Through treatment period, up to 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 29 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABI-H3733 in people with Chronic Hepatitis B, run by Assembly Biosciences at 9 sites in 6 countries.
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 4 inclusion and 5 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Bulgaria, Singapore, Hong Kong, Moldova, New Zealand and 1 more country. 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?
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?
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results (time frame: Through end of study, up to 56 days). 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 29 Jun 2023.