A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 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-4334

Study type: Interventional

Funder types: Industry

Identifiers

NCT06384131

ABI-4334-102

2024-511051-18 (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-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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

ABI-4334

Active Comparator group

Treatment:

Drug: ABI-4334

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo