A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

April 2, 2019 updated by: Assembly Biosciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

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

  • New Zealand
      • Auckland, New Zealand
      • Hamilton, New Zealand

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Healthy volunteers:

  1. Male or female between 18 and 65 years old with a BMI of 18-32kg/m2
  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

CHB patients:

  1. Male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2 and a minimum body weight of 45 kg
  2. Must have chronic hepatitis B with no history of clinical decompensation
  3. Seropositive for HIV, HCV, or HDV antibody at Screen
  4. Previous treatment with any HBV antiviral treatments within the last 3 months
  5. Other known cause of liver disease, including NASH

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABI-H0731 or Matching Placebo
ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
Drug: ABI-H0731
Drug: Placebo for ABI-H0731
Other Names:
  • Sugar pill manufactured to mimic the ABI-H0731 tablet
Experimental: ABI-H0731 or Placebo and ETV or TDF
ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
Drug: ABI-H0731
Drug: Placebo for ABI-H0731
Other Names:
  • Sugar pill manufactured to mimic the ABI-H0731 tablet
Drug: Entecavir
Used to treat adults with chronic hepatitis B virus
Drug: Tenofovir disoproxil fumarate
Used to treat adults with chronic hepatitis B virus
Experimental: ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
Drug: ABI-H0731
Drug: Placebo for ABI-H0731
Other Names:
  • Sugar pill manufactured to mimic the ABI-H0731 tablet
Drug: Pegasys
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Other Names:
  • peginterferon alfa-2a
Drug: Nucleos(t)ide
Used to treat adults with chronic hepatitis B virus

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 57 days
Up to 57 days

Collaborators and Investigators

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

Sponsor

Assembly Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2016

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

June 12, 2018

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABI-H0731-101

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

No

Studies a U.S. FDA-regulated device product

No

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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