Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03109730

Enrollment

Registered

2017-04-12

Start date

2017-06-15

Completion date

2018-06-12

Last updated

2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Brief summary

The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.

Detailed description

The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B patients.

Interventions

DRUGABI-H0731

A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients

DRUGPlacebo for ABI-H0731

Sugar pill manufactured to mimic the ABI-H0731 tablet

DRUGEntecavir

An antiviral medication used in the treatment of hepatitis B virus infection

DRUGTenofovir Disoproxil Fumarate

An antiviral medication used in the treatment of hepatitis B virus infection

DRUGPegasys

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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male or female, 18 to 65 years of age * Chronic HBV infection * Body Mass Index (BMI) 18-38 kg/m2 and a minimum body weight of 45 kg

Exclusion criteria

* Seropositive for HIV, HCV, or HDV antibody at Screen * Previous treatment with any investigational HBV antiviral treatments within the last 6 months * Other known cause of liver disease, including NASH * Other medical condition that requires persistent medical management or chronic or recurrent pharmacologic or surgical intervention

Design outcomes

Primary

Measure	Time frame
Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0.	Up to 57 days

Countries

Australia, Hong Kong, South Korea, Taiwan, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026