Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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.
Query!
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.
Query!
Secondary ID [1]
0
0
AB-101-001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis b
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
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.
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Query!
Primary outcome [2]
0
0
Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
[Time Frame: Up to 196 days]
Query!
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
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Query!
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)
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Query!
Primary outcome [5]
0
0
Part 3: Incidence of clinically significant laboratory abnormalities
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
[Time Frame: Up to 196 days]
Query!
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)
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
[Time Frame: Up to 196 days]
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
60
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/08/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/04/2027
Query!
Actual
Query!
Sample size
Target
164
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
Auckland
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Arbutus Biopharma Corporation
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05960240
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Arbutus Biopharma
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
267-469-0914
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05960240
Download to PDF