Status:
TERMINATED
Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection
Lead Sponsor:
Arbutus Biopharma Corporation
Conditions:
Chronic Hepatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2a/b will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging as...
Eligibility Criteria
Inclusion
- Healthy Subjects
- Male and Female (not of childbearing potential in Part 1 and 2a) subjects between 18 and 45 years old
- Free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results.
- BMI of 18-32 kg/m2.
- CHB Subjects:
- Male or female between 18 and 65 years old.
- 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
- For cohort F, G, H:
- HBV DNA ≥2,000 IU/mL at Screening (subjects may be either treatment-naïve or treatment-experienced but currently off-treatment).
- ALT ≤ 5x ULN
- For Cohort I:
- HBV DNA \<LLOQ at Screening
- 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.
- ALT ≤ 2.5 x ULN
- HbsAg ≥250 IU/mL at screening
Exclusion
- CHB Subjects
- 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.
- Co-infection with HIV or other non-B hepatitis viruses.
- Any clinically significant or unstable medical condition or illness that could confound study findings.
- Subjects who are unwilling to comply with protocol contraception requirements, and female subjects who are pregnant or breastfeeding.
- 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.
Key Trial Info
Start Date :
June 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04775797
Start Date
June 25 2021
End Date
November 17 2022
Last Update
November 21 2022
Active Locations (15)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
2
Nepean Hospital
Kingswood, New South Wales, Australia
3
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
4
Toronto Liver Center
Toronto, Ontario, Canada