NCT03714152

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Assembly Biosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-13
• Primary completion: 2020-11-23
• Completion: 2021-01-07
• First posted: 2018-10-22
• Last updated: 2021-01-27

Locations

14 sites across 7 countries: United States, Australia, China, Hong Kong, New Zealand, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study