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Trial registered on ANZCTR


Registration number
ACTRN12619000954123
Ethics application status
Approved
Date submitted
17/05/2019
Date registered
8/07/2019
Date last updated
1/12/2020
Date data sharing statement initially provided
8/07/2019
Date results information initially provided
1/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study to Investigate the Safety, Tolerability and Pharmacokinetics, of AB-729 Administered by Subcutaneous Injection to Healthy Subjects (part 1)
Scientific title
Part 1 of a three part study- A Study to Investigate the Safety, Tolerability and Pharmacokinetics, of AB-729 Administered by Subcutaneous Injection to Healthy Subjects (part 1)
Secondary ID [1] 297763 0
AB-729-001
Universal Trial Number (UTN)
U1111-1227-7086
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B Infection 312100 0
Condition category
Condition code
Oral and Gastrointestinal 310660 310660 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 311907 311907 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be conducted in 3 parts. Part 1 will be a blinded, single ascending dose (SAD) design and will be conducted in 24 healthy subjects.

Part 1: Subjects will receive single ascending doses consisting of 4 sequential dose groups and this part will be approximately 8 weeks. Approximately 24 healthy subjects will enroll in Part 1. Subjects will receive AB-729 or placebo administered Subcutaneous (SC) injection. The starting dose will be 60 mg. Subsequent doses in Part 1 will be confirmed after review of safety and tolerability from prior dose levels.
Each participant will receive a single dose of AB-729 or placebo only.
All doses of AB-729 will be administered at the study site by study staff members.
Frequency/duration of each dose: Single dose study for Part 1
Intervention code [1] 314003 0
Treatment: Drugs
Comparator / control treatment
Matching placebo will be used for the study only in Part 1.
composition of the placebo treatment: Sterile saline subcutaneous injection
Control group
Placebo

Outcomes
Primary outcome [1] 319512 0
To evaluate the safety and tolerability of AB-729 following administration by SC injection of single doses to healthy subjects as assessed by the frequency and severity of treatment emergent adverse events (TEAEs), discontinuations due to adverse events (AEs), and laboratory abnormalities.

Examples of known/possible adverse reactions/events:
This is a first in human study, so we have no known adverse events to disclose. Based on similar compounds in different early clinical trials, there may be a low incidence of mild redness, bruising or pain at the injection site. This will be assessed by clinical site staff during clinic visits and by participant diaries.
Timepoint [1] 319512 0
Part 1:
Monitored during screening, Day -1, Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 15, Day 22 and Day 29.
Secondary outcome [1] 368515 0
To characterize the single dose PK of AB-729 in healthy subjects.
Single dose PK parameters (e.g., maximum concentration [Cmax]), time to Cmax (Tmax), area under the concentration-time curve from time of dosing to the last measurable concentration [AUC(0-t)].
Timepoint [1] 368515 0
Plasma PK samples will be collected in the following timepoints:
Predose (within 60 minutes prior to dosing), 0.25 hours, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours, 24 hours (Day 2), after 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 96 hours (Day 5), Day 8, Day 15, Day 22 and Day 29.

Eligibility
Key inclusion criteria
Inclusion Criteria for Study Part 1 (Healthy Subjects - SAD):
- Adult male or female subjects aged 18 to 45 years
- Male subjects must agree to use contraception as detailed in the protocol.
- Healthy males or females aged 18 to 45, inclusive. Female subjects may not be of childbearing potential (surgically sterile or post-menopausal).
- Body mass index (BMI) greater than or equal to 18 kg/m2 and lesser than or equal to 32 kg/m2.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria for Study Part 1 (Healthy Subjects – SAD)

Medical Status or History:
- A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary,
neurological, psychiatric, cardiovascular disease, or evidence of active or suspected malignancy, or a
history of malignancy.

Findings/Diagnostic Assessments

- Clinically significant ECG abnormalities or vital sign abnormalities at Screening, Day -1, or Day 1 predose
- Clinically significant abnormalities in laboratory test results at Screening or Day -1, that are confirmed by a repeat reading.
- Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV), hepatitis A virus (HAV)

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
The people administering the treatment/s

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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21354 0
New Zealand
State/province [1] 21354 0
Auckland

Funding & Sponsors
Funding source category [1] 302287 0
Commercial sector/Industry
Name [1] 302287 0
Arbutus Biopharma Corporation
Address [1] 302287 0
100 – 8900 Glenlyon Parkway
Burnaby, British Columbia
Canada V5J 5J8
Country [1] 302287 0
Canada
Primary sponsor type
Commercial sector/Industry
Name
Arbutus Biopharma Corporation
Address
100 – 8900 Glenlyon Parkway
Burnaby, British Columbia
Canada V5J 5J8
Country
Canada
Secondary sponsor category [1] 302162 0
None
Name [1] 302162 0
Address [1] 302162 0
Country [1] 302162 0
Other collaborator category [1] 280614 0
Commercial sector/Industry
Name [1] 280614 0
Novotech (Australia) Pty Limited
Address [1] 280614 0
Level 3, 235 Pyrmont Street, Pyrmont NSW 2009
Country [1] 280614 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302964 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 302964 0
Ministry of Health, Level 3,Rangitoto Room, Unisys Building, 650 Great South Road, Penrose, Auckland, 1051
Ethics committee country [1] 302964 0
New Zealand
Date submitted for ethics approval [1] 302964 0
20/03/2019
Approval date [1] 302964 0
06/05/2019
Ethics approval number [1] 302964 0

Summary
Brief summary
The study drug AB-729 is being developed as a potential new treatment for Chronic Hepatitis B (CHB). The main goal of the study is to determine whether AB-729 is safe and well tolerated when given at different doses. We will also measure the levels of the drug in the blood at different times.
The study will be conducted in 3 parts. Part 1 will be a blinded, single ascending dose (SAD) design and will be conducted in 24 healthy subjects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91998 0
Prof Edward Gane
Address 91998 0
Auckland Clinical Studies Ltd and Auckland City Hospital, PO Box 8963, Symonds St, Auckland, 1150
Country 91998 0
New Zealand
Phone 91998 0
+64 21548371
Fax 91998 0
Email 91998 0
EdGane@adhb.govt.nz
Contact person for public queries
Name 91999 0
Mr Michael Child
Address 91999 0
Arbutus Biopharma Corporation,
701 Veterans Circle
Warminster, Pennsylvania
United States , 18974
Country 91999 0
United States of America
Phone 91999 0
+1 267 469 0914
Fax 91999 0
Email 91999 0
clinicaltrials@arbutusbio.com
Contact person for scientific queries
Name 92000 0
Mr Michael Child
Address 92000 0
Arbutus Biopharma Corporation,
701 Veterans Circle
Warminster, Pennsylvania
United States , 18974
Country 92000 0
United States of America
Phone 92000 0
+1 267 469 0914
Fax 92000 0
Email 92000 0
clinicaltrials@arbutusbio.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary