NCT06384131

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

A Randomized, Blinded, Placebo-Controlled Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Assembly Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	ABI-4334	10 mg or 50 mg tablets for oral administration
DRUG	Placebo	10 mg or 50 mg tablets for oral administration

Timeline

• Start date: 2024-06-04
• Primary completion: 2025-04-15
• Completion: 2025-05-14
• First posted: 2024-04-25
• Last updated: 2025-07-23

Locations

2 sites across 2 countries: Moldova, New Zealand