A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

Assembly Biosciences

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: Placebo for ABI-H0731; Drug: Nucleos(t)ide; Drug: Tenofovir disoproxil fumarate; Drug: ABI-H0731; Drug: Pegasys; Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02908191

ABI-H0731-101

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 3 patient groups

ABI-H0731 or Matching Placebo

Experimental group

Description:

ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days

Treatment:

Drug: ABI-H0731

Drug: Placebo for ABI-H0731

ABI-H0731 or Placebo and ETV or TDF

Experimental group

Description:

ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days

Treatment:

Drug: Tenofovir disoproxil fumarate

Drug: ABI-H0731

Drug: Entecavir

Drug: Placebo for ABI-H0731

ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys

Experimental group

Description:

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

Treatment:

Drug: ABI-H0731

Drug: Nucleos(t)ide

Drug: Pegasys

Drug: Placebo for ABI-H0731