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

Primary Purpose

Chronic Hepatitis b

Status
Not yet recruiting
Phase
Phase 1
Locations
New Zealand
Study Type
Interventional
Intervention
AB-101
Placebo
Nucleos(t)ide Analogue
Sponsored by
Arbutus Biopharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis b

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • New Zealand Clinical Research Auckland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 1

Part 2

Part 3

Arm Description

Outcomes

Primary Outcome Measures

Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs.
Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs
Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities
Parts 1 and 2: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
Part 3: Incidence of clinically significant laboratory abnormalities
Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)

Secondary Outcome Measures

Full Information

First Posted
July 14, 2023
Last Updated
July 26, 2023
Sponsor
Arbutus Biopharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05960240
Brief Title
Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbutus Biopharma Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1
Arm Type
Experimental
Arm Title
Part 2
Arm Type
Experimental
Arm Title
Part 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AB-101
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Name(s)
Nucleos(t)ide Analogue
Intervention Description
Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B.
Primary Outcome Measure Information:
Title
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
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Title
Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs
Time Frame
[Time Frame: Up to 196 days]
Title
Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities
Time Frame
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Title
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
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Title
Part 3: Incidence of clinically significant laboratory abnormalities
Time Frame
[Time Frame: Up to 196 days]
Title
Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
Time Frame
[Time Frame: Up to 196 days]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arbutus Biopharma
Phone
267-469-0914
Email
clinicaltrials@arbutusbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Varun Sharma
Phone
267-391-7103
Email
vsharma@arbutusbio.com
Facility Information:
Facility Name
New Zealand Clinical Research Auckland
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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