NCT06384131CompletedPhase 1
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 22 Apr 2024
- Start date
- 4 Jun 2024
- Primary completion date
- 15 Apr 2025
- Lead sponsor
- Assembly Biosciences
- Diseases
- Hepatitis B
- NCT number
- NCT06384131
- EudraCT number
- 2024-511051-18
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 20
- From 4 Jun 2024 to the primary completion date, 15 Apr 2025
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arensia Exploratory Medicine Chisinau Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| New Zealand Clinical Research Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.