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

Assembly Biosciences31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

ABI-H3733DRUG

25 mg or 100 mg tablets for oral administration

PlaceboDRUG

25 mg or 100 mg tablets for oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (9)

Diagnostic Consultative Center Aleksandrovska

Sofia, Sofia-Grad, Bulgaria

Acibadem City Clinic Tokuda Hospital

Sofia, Bulgaria

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, Bulgaria

Outcomes

Primary Outcomes

Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results

Time frame: Through end of study, up to 56 days