A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assembly Biosciences

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

5. Current or prior treatment for cHBV