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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05960240




Registration number
NCT05960240
Ethics application status
Date submitted
14/07/2023
Date registered
25/07/2023
Date last updated
23/02/2024

Titles & IDs
Public title
Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.
Scientific 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.
Secondary ID [1] 0 0
AB-101-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis b 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AB-101
Treatment: Drugs - Placebo
Treatment: Drugs - Nucleos(t)ide Analogue

Experimental: Part 1 -

Experimental: Part 2 -

Experimental: Part 3 -


Treatment: Drugs: 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.

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

Treatment: Drugs: Nucleos(t)ide Analogue
Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs.
Timepoint [1] 0 0
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Primary outcome [2] 0 0
Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs
Timepoint [2] 0 0
[Time Frame: Up to 196 days]
Primary outcome [3] 0 0
Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities
Timepoint [3] 0 0
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Primary outcome [4] 0 0
Parts 1 and 2: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
Timepoint [4] 0 0
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Primary outcome [5] 0 0
Part 3: Incidence of clinically significant laboratory abnormalities
Timepoint [5] 0 0
[Time Frame: Up to 196 days]
Primary outcome [6] 0 0
Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
Timepoint [6] 0 0
[Time Frame: Up to 196 days]

Eligibility
Key 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

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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Part 1 and 2 (Healthy Volunteers)

Key

* 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.

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
164
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arbutus Biopharma Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05960240
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Arbutus Biopharma
Address 0 0
Country 0 0
Phone 0 0
267-469-0914
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05960240