drugset / Trial / NCT05414981

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

NCT05414981 ↗

Phase 1 Completed 31 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-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.

Timeline

Start
2022-08-07
Primary completion
2023-04-24
Completion
2023-04-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator ABI-H3733 Unknown 25 mg Oral
Comparator ABI-H3733 Unknown 100 mg Oral