A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

Phase 1

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: ABI-H0731; Drug: Placebo for ABI-H0731; Drug: Pegasys; Drug: Entecavir; Drug: Nucleos(t)ide; Drug: Tenofovir disoproxil fumarate

• Registration Number: NCT02908191
• Lead Sponsor: Assembly Biosciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-20
• Study Start: 2016-11
• Primary Completion: 2018-03-31
• Study Completion: 2018-06-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys	ABI-H0731	ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys	Pegasys	ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
ABI-H0731 or Placebo and ETV or TDF	Placebo for ABI-H0731	ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
ABI-H0731 or Matching Placebo	ABI-H0731	ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
ABI-H0731 or Placebo and ETV or TDF	ABI-H0731	ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
ABI-H0731 or Matching Placebo	Placebo for ABI-H0731	ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys	Placebo for ABI-H0731	ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys	Nucleos(t)ide	ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
ABI-H0731 or Placebo and ETV or TDF	Entecavir	ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
ABI-H0731 or Placebo and ETV or TDF	Tenofovir disoproxil fumarate	ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days

Primary Outcome Measures

Name	Time	Method
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.	Up to 57 days