Clinical Trial

Testing Hepatitis Medication in Healthy Subjects

Study Description

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

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - ABI-H2158

5 mg or 25 mg tablets

Drug - Placebo for ABI-H2158

Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets

Additional Information

Official Study Title

A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single and Multiple Doses of ABI-H2158 in Healthy Volunteers; and the Multiple-Ascending Dose Pharmacokinetics and Pharmacodynamics in Patients With Chronic Hepatitis B Infection

Clinical Trial ID

NCT03714152

ParticipAid ID

bqx22a