NCT02908191

A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

A Phase 1a/1b, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Healthy Volunteers and Patients With Chronic Hepatitis B

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Assembly Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	ABI-H0731
DRUG	Placebo for ABI-H0731
DRUG	Entecavir	Used to treat adults with chronic hepatitis B virus
DRUG	Tenofovir disoproxil fumarate	Used to treat adults with chronic hepatitis B virus
DRUG	Pegasys	Used to treat adults with chronic hepatitis B virus who show signs of liver damage
DRUG	Nucleos(t)ide	Used to treat adults with chronic hepatitis B virus

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-03-31
• Completion: 2018-06-12
• First posted: 2016-09-20
• Last updated: 2019-04-04

Locations

2 sites across 1 country: New Zealand