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Completed

NCT Number: NCT02908191

A Study 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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Auckland, New Zealand

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Healthy volunteers:

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

  • 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
  • Must have chronic hepatitis B with no history of clinical decompensation
  • Seropositive for HIV, HCV, or HDV antibody at Screen
  • Previous treatment with any HBV antiviral treatments within the last 3 months
  • Other known cause of liver disease, including NASH

Treatment and study plan

ABI-H0731

Drug

Placebo for ABI-H0731

Drug

Other names: Sugar pill manufactured to mimic the ABI-H0731 tablet

Entecavir

Drug

Used to treat adults with chronic hepatitis B virus

Tenofovir disoproxil fumarate

Drug

Used to treat adults with chronic hepatitis B virus

Pegasys

Drug

Used to treat adults with chronic hepatitis B virus who show signs of liver damage

Other names: peginterferon alfa-2a

nucleos(t)ide

Drug

Used to treat adults with chronic hepatitis B virus

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assembly Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 20, 2016
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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