A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection

NCT ID: NCT06384131

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-04

Study Completion Date

2025-05-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis B

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Triple (Participant, Care Provider, Investigator)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ABI-4334

Group Type ACTIVE_COMPARATOR

ABI-4334

Intervention Type DRUG

10 mg or 50 mg tablets for oral administration

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

10 mg or 50 mg tablets for oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABI-4334

10 mg or 50 mg tablets for oral administration

Intervention Type DRUG

Placebo

10 mg or 50 mg tablets for oral administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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
2. Chronic hepatitis B infection, defined as HBV infection for ≥ 6 months documented
3. Treatment-naïve or off-antiviral therapy for ≥ 24 weeks prior to Screening
4. Lack of bridging fibrosis or cirrhosis

Exclusion Criteria

1. 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)
2. History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation
3. Clinically significant diseases or conditions
4. History of hepatocellular carcinoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assembly Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ARENSIA Exploratory Medicine Chisinau

Chisinau, , Moldova

Site Status

New Zealand Clinical Research

Auckland, , New Zealand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Moldova New Zealand

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-511051-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ABI-4334-102

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study in Healthy Volunteers
NCT03596697 COMPLETED PHASE1