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

Chronic Hepatitis b Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05960240
• Other study ID #: AB-101-001
• Status: Recruiting
• Phase: Phase 1
• Start date: August 30, 2023
• Est. completion date: April 2027

Study information

• Verified date: July 2023
• Source: Arbutus Biopharma Corporation
• Contact: Arbutus Biopharma
• Phone: 267-469-0914
• Email: clinicaltrials[@]arbutusbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: April 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis B
• Hepatitis B, Chronic

Intervention

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

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research Auckland	Grafton	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Arbutus Biopharma Corporation

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Primary	Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs		[Time Frame: Up to 196 days]
Primary	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]
Primary	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]
Primary	Part 3: Incidence of clinically significant laboratory abnormalities		[Time Frame: Up to 196 days]
Primary	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]