drugset / Trial / NCT03714152

A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B

NCT03714152

Phase 1 Completed 80 enrolled Assembly Biosciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.

Timeline

Start
2018-11-13
Primary completion
2020-11-23
Completion
2021-01-07

Drugs

EvaluationDrugModalityDoseRoute
Subject ABI-H2158 Unknown 5 mg Oral
Subject ABI-H2158 Unknown 25 mg Oral