CompletedPhase 1

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

Moldova, New Zealand20 participantsStarted 2024-06-04

Plain-language 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. 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses

Timeframe: Through end of study, up to 56 days

Trial details

NCT IDNCT06384131

SponsorAssembly Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-15

View on ClinicalTrials.gov More Chronic Hepatitis B trials