A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects with Chronic Hepatitis B Virus Infection

Phase 1

Recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: ABI-4334; Drug: Placebo

• Registration Number: NCT06384131
• 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-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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-25
• Study Start: 2024-05-08
• Status Verified: 2024-09
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABI-4334	ABI-4334	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses	Through end of study, up to 56 days	Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results

Secondary Outcome Measures

Name	Time	Method
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV	Through treatment period, up to 28 days	Time to Maximum Plasma Concentration (Tmax) of ABI-4334 in subjects with cHBV
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334	Through treatment period, up to 28 days	Mean time elapsed to subjects achieving HBV DNA \< LLOQ and/or LOD
Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV	Through treatment period, up to 28 days
Changes in HBV pregenomic ribonucleic acid (pgRNA) and additional markers of antiviral activity in subjects with cHBV	Through treatment period, up to 28 days	To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV

Trial Locations

Locations (5)

ARENSIA Exploratory Medicine S.R.L.; 🇷🇴 Bucharest, Romania

ARENSIA Exploratory Medicine Cluj-Napoca; 🇧🇬 Sofia, Bulgaria

ARENSIA Exploratory Medicine Chisinau; 🇲🇩 Chisinau, Moldova, Republic of

New Zealand Clinical Research; 🇳🇿 Auckland, New Zealand

ARENSIA Exploratory Medicine SRL; 🇷🇴 Cluj-Napoca, Romania