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

Assembly Biosciences

Status and phase

Completed

Phase 1

Conditions

Chronic Hepatitis B

Treatments

Drug: Placebo

Drug: ABI-H3733

Study type

Interventional

Funder types

Industry

Identifiers

NCT05414981

ABI-H3733-102

2022-000318-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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
Current or prior treatment for cHBV