drugset / Trial / NCT06384131

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

NCT06384131 ↗

Phase 1 Completed 20 enrolled Assembly Biosciences
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2024-06-04
Primary completion
2025-04-15
Completion
2025-05-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator ABI-4334 Unknown 10 mg Oral
Comparator ABI-4334 Unknown 50 mg Oral