None listed
Conditions
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 2 will be an open-label, non-randomized, SAD design and will be conducted in up to 30 subjects with CHB infection.
Interventions
The study will be conducted in 3 parts. Part 2 will be an open-label, SAD design and will be conducted in up to 30 subjects with CHB infection. Part 2: This part will be approximately up to 48 weeks. Approximately 30 non-cirrhotic subjects with CHB infection will enroll in Part 2 in up to 5 cohorts (Cohorts A, B, C, D and H)..
The starting dose of AB-729 administered to Cohort A will be approved by the Investigator and Sponsor Medical Monitor based on safety and tolerability data from the two i
The study will be conducted in 3 parts. Part 2 will be an open-label, SAD design and will be conducted in up to 30 subjects with CHB infection. Part 2: This part will be approximately up to 48 weeks. Approximately 30 non-cirrhotic subjects with CHB infection will enroll in Part 2 in up to 5 cohorts (Cohorts A, B, C, D and H).. The starting dose of AB-729 administered to Cohort A will be approved by the Investigator and Sponsor Medical Monitor based on safety and tolerability data from the two initial single doses in healthy subjects in Part 1 and will not exceed the maximum dose found to be safe and tolerable. Doses in subsequent cohorts will not exceed those tested in Part 1 and are subject to approval of the Investigator, Sponsor Medical Monitor, and an independent external safety reviewer with expertise in HBV. All doses of AB-729 will be administered at the study site by study staff members. Each participant will receive a single dose of AB-729 only. Frequency/duration of each dose: Single dose study for Part 2 mode of administration: Subcutaneous injection
Sponsors
Arbutus Biopharma Corporation
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Male subjects must agree to use contraception as detailed in the protocol. - Female subjects must not be pregnant and must agree to use contraception as detailed in the protocol. - BMI greater than or equal to 18 kg/m2 and lesser than or equal to 38 kg/m2. - Documented chronic HBV infection as defined in the protocol - HBV-DNA at screening: For HBV-DNA+ subjects (Cohorts D) only: HBV-DNA greater than or equal to 1,000 IU/mL at Screening. For HBV-DNA- subjects (Cohorts A, B, C and H) only: HBV-DNA must be lower than the limit of quantitation at Screening
Exclusion criteria
Exclusion Criteria for Study Part 2: Known co-infection with any of the following: a. HIV, b. acute hepatitis A virus (HAV), c. HCV, d. hepatitis D virus (HDV), OR e. acute hepatitis E virus (HEV) infection. Any known preexisting medical or psychiatric condition that could interfere with the subject’s ability to provide informed consent or participate in study conduct, or that may confound study findings including, but not limited to: a. History of any clinically significant medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson’s disease, a-1-antitrypsin deficiency, alcoholic liver disease, non-alcoholic steatohepatitis, or toxin exposures) that may affect the ability to respond to HBV therapy. b. Immunologically mediated disease or significant immunosuppresion d. Current or history of any clinically significant cardiac abnormalities/dysfunction or uncontrolled hypertension. e. Evidence of decompensated liver disease or findings suggestive of HCC at any time. Evidence of active or suspected malignancy, or a history of malignancy Findings/Diagnostic Assessments at Screening, confirmed by repeat testing: - ALT or AST >5 × upper limit of normal (ULN). - Total bilirubin >1.5 × ULN. - Alpha fetoprotein (AFP) >100 ng/mL
Outcome results
None listed