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

January 26, 2021 updated by: Assembly Biosciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Clayton, Victoria, Australia
        • Monash University
      • Melbourne, Victoria, Australia
        • The Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Linear Clinical Research
  • China
    • Changchun
      • Jilin, Changchun, China, 130000
        • First Hospital of Jilin University
  • Hong Kong
      • Hong Kong, Hong Kong
        • University of Hong Kong, Queen Mary Hospital
  • Korea, Republic of
      • Chuncheon, Korea, Republic of
        • Hallym University
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University
  • New Zealand
      • Auckland, New Zealand
        • Auckland Clinical Studies
  • United Kingdom
      • London, United Kingdom
        • King's College London
  • United States
    • California
      • Coronado, California, United States, 92118
        • Southern California Research Center
      • San Diego, California, United States, 92115
        • Research and Education
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • Infectious Disease Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Healthy volunteers:

  1. Male or female between 18 and 55 years old with a BMI of 18-34 kg/m2 with a minimum body weight of 45 kg
  2. Must be in good health and not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study

Chronic HBV patients:

Key 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABI-H2158
ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days
Drug: ABI-H2158
5 mg or 25 mg tablets
Placebo Comparator: Matching Placebo for ABI-H2158
Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days
Drug: Placebo for ABI-H2158
Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
Time Frame: Up to 28 days
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assembly Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2018

Primary Completion (Actual)

November 23, 2020

Study Completion (Actual)

January 7, 2021

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABI-H2158-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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