Chronic Hepatitis BPhase 1NCT06384131
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection
A Phase 1 study testing ABI-4334 in people with Chronic Hepatitis B, run by Assembly Biosciences at 2 sites in 2 countries.
Trial summary
This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 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-4334
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Jun 2024to 14 May 2025
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Blinded, Placebo-Controlled Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 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-4334 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-4334 or placebo.
- Conditions
- Chronic Hepatitis B
- Being tested
- ABI-4334, 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-4334Drug
10 mg or 50 mg tablets for oral administration
PlaceboDrug
10 mg or 50 mg tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| ABI-4334 | Active comparator | Not described Receives: Drug: ABI-4334 |
| 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.
To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses
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 (8)
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
Noncompartmental plasma PK parameters
Measured: Through treatment period, up to 28 days
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
Mean change in log10 HBV DNA between Baseline and Day 28
Measured: Through treatment period, up to 28 days
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
Area Under Plasma Concentration-Time Curve (AUC) of ABI-4334 in subjects with cHBV
Measured: Through treatment period, up to 28 days
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
Time to Maximum Plasma Concentration (Tmax) of ABI-4334 in subjects with cHBV
Measured: Through treatment period, up to 28 days
Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV
Measured: Through treatment period, up to 28 days
Changes in HBV pregenomic ribonucleic acid (pgRNA) and additional markers of antiviral activity in subjects with cHBV
To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV
Measured: Through treatment period, up to 28 days
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
Proportion of subjects with HBV DNA < lower limit of quantification (LLOQ) and/or limit of detection (LOD)
Measured: Through treatment period, up to 28 days
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
Mean time elapsed to subjects achieving HBV DNA < LLOQ and/or LOD
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 posted25 Apr 2024
- Study start4 Jun 2024
- Primary completion15 Apr 2025
- Study completion14 May 2025
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
- 20 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
- NCT06384131
- Sponsor's protocol ID
- ABI-4334-102
- Other IDs
- 2024-511051-18
- Status last verified
- Jun 2025
- First submitted
- 22 Apr 2024
- Last updated
- 23 Jul 2025
- 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 23 Jul 2025. 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-4334 in Subjects With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT06384131
- Acronym / sponsor ID
- ABI-4334-102
- Conditions
- Chronic Hepatitis B
- Keywords
- cHBV, HBV, Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 25 Apr 2024 (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-4334 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-4334 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-4334 | Active comparator | Drug: ABI-4334 |
| 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 (4 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
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-433410 mg or 50 mg tablets for oral administration | Drug | ABI-4334 |
| Placebo10 mg or 50 mg tablets for oral administration | Drug | Placebo |
Primary outcome
To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses
Time frame: Through end of study, up to 56 days
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
8 secondary outcomes
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
Time frame: Through treatment period, up to 28 days
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
Time frame: Through treatment period, up to 28 days
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
Time frame: Through treatment period, up to 28 days
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
Time frame: Through treatment period, up to 28 days
Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV
Time frame: Through treatment period, up to 28 days
Changes in HBV pregenomic ribonucleic acid (pgRNA) and additional markers of antiviral activity in subjects with cHBV
Time frame: Through treatment period, up to 28 days
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
Time frame: Through treatment period, up to 28 days
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
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 23 Jul 2025.
- 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABI-4334 in people with Chronic Hepatitis B, run by Assembly Biosciences at 2 sites in 2 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 4 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Moldova, New Zealand. 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?
To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses (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 23 Jul 2025.