A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
- Registration Number
- NCT05414981
- Lead Sponsor
- Assembly Biosciences
- Brief Summary
This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 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-H3733 or placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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
- 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
- Current or prior treatment for cHBV
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABI-H3733 ABI-H3733 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results Through end of study, up to 56 days
- Secondary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV Through treatment period, up to 28 days Minimum Plasma Concentration (Cmin) of ABI-H3733 in subjects with cHBV Through treatment period, up to 28 days Area Under Plasma Concentration-Time Curve (AUC) of ABI-H3733 in subjects with cHBV Through treatment period, up to 28 days Time to Maximum Plasma Concentration (Tmax) of ABI-H3733 in subjects with cHBV Through treatment period, up to 28 days Elimination half-life (t1/2) of ABI-H3733 in subjects with cHBV Through treatment period, up to 28 days To evaluate the effect of food on Cmax of ABI-H3733 in subjects with cHBV Through treatment period, up to 28 days To evaluate the effect of food on AUC of ABI-H3733 in subjects with cHBV Through treatment period, up to 28 days To evaluate the effect of food on the proportion of subjects with AEs, premature discontinuation due to AEs and abnormal laboratory results Through treatment period, up to 28 days To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV by Quantitative PCR Through treatment period, up to 28 days
Trial Locations
- Locations (9)
Diagnostic Consultative Center Aleksandrovska
🇧🇬Sofia, Sofia City, Bulgaria
National University Hospital
🇸🇬Singapore, Singapore
Clinical Trials and Research Centre, Singapore General Hospital
🇸🇬Singapore, Singapore
New Zealand Clinical Research
🇳🇿Grafton, Auckland, New Zealand
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
🇧🇬Sofia, Bulgaria
Acibadem City Clinic Tokuda Hospital
🇧🇬Sofia, Bulgaria
Institute of Infectious Diseases - Hospital ARENSIA Exploratory Medicine Research Clinic National Institute of Infectious Diseases "Matei Bals"
🇷🇴Bucharest, Romania
ICS Arensia Exploratory Medicine Republican Clinical Hospital "Timofei Moșneaga"- Hospital
🇲🇩Chisinau, Moldova, Republic of
University of Hong Kong
🇭🇰Hong Kong, Hong Kong