Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2026-04-30

Brief Summary

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This three-part, Phase 1 protocol will be the first clinical study of AB-101. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-101 in healthy adult subjects.

Part 3 will be a Phase 1b dose-ranging assessment of AB-101 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.

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Detailed Description

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Conditions

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Chronic Hepatitis b

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Part 1

Group Type EXPERIMENTAL

AB-101

Intervention Type DRUG

AB-101 is an oral small molecule PD-L1 checkpoint inhibitor being developed for the treatment of chronic infection with HBV in combination with other agents.

Placebo

Intervention Type DRUG

A placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study.

Part 2

Group Type EXPERIMENTAL

AB-101

Intervention Type DRUG

AB-101 is an oral small molecule PD-L1 checkpoint inhibitor being developed for the treatment of chronic infection with HBV in combination with other agents.

Placebo

Intervention Type DRUG

A placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study.

Part 3

Group Type EXPERIMENTAL

AB-101

Intervention Type DRUG

AB-101 is an oral small molecule PD-L1 checkpoint inhibitor being developed for the treatment of chronic infection with HBV in combination with other agents.

Placebo

Intervention Type DRUG

A placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study.

Nucleos(t)ide Analogue

Intervention Type DRUG

Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B.

Interventions

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AB-101

AB-101 is an oral small molecule PD-L1 checkpoint inhibitor being developed for the treatment of chronic infection with HBV in combination with other agents.

Intervention Type DRUG

Placebo

A placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study.

Intervention Type DRUG

Nucleos(t)ide Analogue

Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male between ages 18-50 years
* Willing and able to provide informed consent

Willing to follow protocol-specified contraception requirement

* Male or female subjects between the ages of 18-60 years
* Willing to provide informed consent
* Chronic HBV infection for at least 6 months
* Willing to follow protocol-specified contraception requirement

Exclusion Criteria

* Clinically significant lab abnormalities
* A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, autoimmune or other immune-mediated disease.
* HIV or Hep C positive
* Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.

* Have extensive fibrosis or cirrhosis of the liver
* Have or had liver cancer (hepatocellular carcinoma)
* Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study
* Females who breastfeeding, pregnant or who wish to become pregnant during the study
* Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes