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

Phase 1

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Placebo for ABI-H2158; Drug: ABI-H2158

• Registration Number: NCT03714152
• Lead Sponsor: Assembly Biosciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Study Start: 2018-11-13
• Primary Completion: 2020-11-23
• Status Verified: 2021-01
• Study Completion: 2021-01-07
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Male or female ≥ 18 and ≤ 65 years of age.

2. In good general health except for chronic HBV infection, documented by:

   1. Clinical history, physical exam and routine laboratory measurements without major or clinically significant findings
   2. Serologic profile consistent with chronic HBV infection • HBeAg-positive at Screening with HBV viral load ≥ 2× 105 IU/mL

3. Liver evaluation demonstrating the absence of bridging fibrosis or cirrhosis

Key

Exclusion Criteria

1. History or evidence of decompensated liver disease at any time prior to Screening
2. History or presence of any other clinically significant current medical conditions requiring ongoing pharmacological treatment.
3. Previous treatment with any investigational HBV antiviral treatments within the last 6 months, or previous treatment at any time with an investigational HBV antiviral treatment of the same class (core protein targeted therapies).
4. Previous treatment with a commercially approved HBV therapy within the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching Placebo for ABI-H2158	Placebo for ABI-H2158	Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days
ABI-H2158	ABI-H2158	ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 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 28 days

Trial Locations

Locations (14)

Southern California Research Center; 🇺🇸 Coronado, California, United States

Research and Education; 🇺🇸 San Diego, California, United States

Quest Clinical Research; 🇺🇸 San Francisco, California, United States

Linear Clinical Research; 🇦🇺 Nedlands, Western Australia, Australia

First Hospital of Jilin University; 🇨🇳 Jilin, Changchun, China

Hallym University; 🇰🇷 Chuncheon, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University; 🇰🇷 Seoul, Korea, Republic of

Auckland Clinical Studies; 🇳🇿 Auckland, New Zealand

King's College London; 🇬🇧 London, United Kingdom

Monash University; 🇦🇺 Clayton, Victoria, Australia

Infectious Disease Care; 🇺🇸 Hillsborough, New Jersey, United States

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

University of Hong Kong, Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong