Trial | NCT02908191  Report issue

Title

A Study in Healthy Volunteers and Patients With Chronic Hepatitis B
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    entecavir tenofovir abi-h0731 ...

  • Study Participants

    86
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 Started
Nov 30
2016
Primary Completion
Mar 31
2018
Study Completion
Jun 12
2018
Last Update
Apr 04
2019

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

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

ABI-H0731 or Matching Placebo Experimental

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 Experimental

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 a Nucleos(t)ide and Pegasys Experimental

ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days

Criteria 

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
No Results Posted