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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04775797




Registration number
NCT04775797
Ethics application status
Date submitted
24/02/2021
Date registered
1/03/2021

Titles & IDs
Public title
Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection
Scientific title
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AB-836, an HBV Capsid Inhibitor, in Healthy Subjects and Subjects With Chronic HBV Infection
Secondary ID [1] 0 0
AB-836-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AB-836
Treatment: Drugs - Placebo
Treatment: Drugs - AB-836
Treatment: Drugs - Placebo
Treatment: Drugs - Nucleos(t)ide Analogue

Experimental: Part 1 (Healthy Subjects): Single Ascending Dose (SAD) - Two cohorts (Cohorts A and B) of healthy subjects will receive single doses of AB-836/placebo in an alternating cohort design under fasted conditions. One additional treatment will be administered under fed conditions.

Experimental: Part 2a (Healthy Subjects): Multiple Ascending Dose (MAD) - Participants in Cohorts C, D and E will receive a once daily dose of AB-836/placebo for 10 days

Experimental: Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohorts F-H - Participants in Cohorts F, G, and H will receive multiple doses of AB-836/placebo once daily for 28 days.

Experimental: Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohort I - Participants in Cohort I will receive multiple doses of AB-836/placebo once daily for 28 days in combination with ongoing nucleos(t)ide analog (NA) therapy.

Experimental: Part 2b (Healthy Subjects): MAD - Participants in Cohorts J will receive a once daily dose of AB-836/placebo for 35 days


Treatment: Drugs: AB-836
Capsules or Tablets

Treatment: Drugs: Placebo
Capsules of Tablets

Treatment: Drugs: AB-836
Tablets

Treatment: Drugs: Placebo
Tablets

Treatment: Drugs: Nucleos(t)ide Analogue
Tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of TEAEs
Timepoint [1] 0 0
Up to 35 days after last dose of AB-836/placebo
Primary outcome [2] 0 0
Incidence of discontinuations due to AEs
Timepoint [2] 0 0
Up to 35 days after last dose of AB-836/placebo
Primary outcome [3] 0 0
Incidence of lab abnormalities
Timepoint [3] 0 0
Up to 35 days after last dose of AB-836/placebo

Eligibility
Key inclusion criteria
* Healthy Subjects

1. Male and Female (not of childbearing potential in Part 1 and 2a) subjects between 18 and 45 years old
2. Free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results.
3. BMI of 18-32 kg/m2.
* CHB Subjects:

1. Male or female between 18 and 65 years old.
2. Chronic HBV infection documented as a positive HBsAg, HBV DNA, or HBeAg test at least 6 months prior to the Screening Visit, or a historical liver biopsy consistent with chronic HBV infection
3. For cohort F, G, H:

1. HBV DNA =2,000 IU/mL at Screening (subjects may be either treatment-naïve or treatment-experienced but currently off-treatment).
2. ALT = 5x ULN
4. For Cohort I:

1. HBV DNA <LLOQ at Screening
2. Subjects must have been receiving either TAF, TDF, or ETV consistently for =6 months prior to Day 1 and are willing to continue with the same NA treatment through the final study visit.
3. ALT = 2.5 x ULN
5. HbsAg =250 IU/mL at screening
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* CHB Subjects

1. Advanced fibrosis, cirrhosis or other signs of advanced liver disease as assessed by clinical history, ultrasound or FibroScan, or history of cirrhosis or any clinically significant medical condition associated with chronic liver disease.
2. Co-infection with HIV or other non-B hepatitis viruses.
3. Any clinically significant or unstable medical condition or illness that could confound study findings.
4. Subjects who are unwilling to comply with protocol contraception requirements, and female subjects who are pregnant or breastfeeding.
5. Previous treatment with a capsid inhibitor, core inhibitor, or core protein assembly modifier [CpAM or CAM]) within 6 months of the Day 1 visit, or prior treatment with an HBV-targeted siRNA or antisense oligonucleotide compound at any time.

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

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/11/2022
Sample size
Target
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Kingswood
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Hong Kong
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Busan
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul
Country [5] 0 0
Moldova, Republic of
State/province [5] 0 0
Chisinau
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
Thailand
State/province [7] 0 0
Bangkok
Country [8] 0 0
Thailand
State/province [8] 0 0
Chiang Mai
Country [9] 0 0
Thailand
State/province [9] 0 0
Khon Kaen
Country [10] 0 0
Thailand
State/province [10] 0 0
Phitsanulok
Country [11] 0 0
Ukraine
State/province [11] 0 0
Kyiv

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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 Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04775797