Clinical trial

A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study Evaluating the Safety, Tolerability, PK and PD of AB-101, an Oral PD-L1 Inhibitor, in Healthy Subjects and Subjects With Chronic HBV Infection.

Name

AB-101-001

Description

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.

Trial arms

Trial start

2023-08-30

Estimated PCD

2026-12-01

Trial end

2027-04-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Part 1, Part 2, Part 3

Placebo

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

Arms:

Part 1, Part 2, Part 3

Nucleos(t)ide Analogue

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

Arms:

Part 3

Size

164

Primary endpoint

Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs.

[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]

Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs

[Time Frame: Up to 196 days]

Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities

[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]

Parts 1 and 2: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)

[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]

Part 3: Incidence of clinically significant laboratory abnormalities

[Time Frame: Up to 196 days]

Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)

[Time Frame: Up to 196 days]

Eligibility criteria

Inclusion Criteria: Part 1 and 2 (Healthy Volunteers) * Male between ages 18-50 years * Willing and able to provide informed consent Willing to follow protocol-specified contraception requirement Inclusion Criteria: Part 3 (CHB Subjects) * 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: Part 1 and 2 (Healthy Volunteers) Key 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. Exclusion Criteria: Part 3 (CHB Subjects) * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 164, 'type': 'ESTIMATED'}}

Updated at

2024-02-23

1 organization

5 products

1 indication

Product

Indication

Organization

Product

Product

Product

Nucleos(t)ide Analogue

Product

Nucleoside Analogue