Assessing a new treatment for chronic Hepatitis B 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
This study is testing a new treatment called ABI-4334 to see if it can help people with chronic Hepatitis B feel better compared to a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assembly Biosciences Industry-sponsored |
| Locations | 5 sites (Sofia and 4 other locations) |
| Trial ID | NCT06384131 on ClinicalTrials.gov |
What this trial studies
This is a randomized, blinded, placebo-controlled Phase 1b study evaluating the safety, pharmacokinetics, and antiviral activity of ABI-4334 in individuals with chronic Hepatitis B virus infection. The study will enroll up to 50 treatment-naïve or off-treatment subjects, who will be randomized to receive either ABI-4334 or a placebo in a ratio of 8:2. Participants will be monitored for safety and efficacy over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic Hepatitis B infection who are treatment-naïve or have been off antiviral therapy for at least 24 weeks.
Not a fit: Patients with co-infections, advanced liver disease, or a history of liver transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with chronic Hepatitis B infection.
How similar studies have performed: Other studies have explored antiviral treatments for Hepatitis B, but the specific approach of ABI-4334 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sofia and 4 other locations
- ARENSIA Exploratory Medicine Cluj-Napoca — Sofia, Bulgaria (Not_yet_recruiting)
- ARENSIA Exploratory Medicine Chisinau — Chisinau, Moldova, Republic of (Recruiting)
- New Zealand Clinical Research — Auckland, New Zealand (Recruiting)
- ARENSIA Exploratory Medicine S.R.L. — Bucharest, Romania (Not_yet_recruiting)
- ARENSIA Exploratory Medicine SRL — Cluj-Napoca, Romania (Not_yet_recruiting)
Study contacts
- Study coordinator: Assembly Biosciences
- Email: clinicaltrials@assemblybio.com
- Phone: 833-509-4583
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.