A Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB-729 Administered by Subcutaneous Injection to Subjects with Chronic Hepatitis B Infectio

Phase 1

Active, not recruiting

• Conditions: Chronic Hepatitis B Infection (CHB); Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620000295943
• Lead Sponsor: Arbutus Biopharma Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-04
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Inclusion Criteria for Study Part 3:
- 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 G) only: HBV-DNA greater than or equal to 1,000 IU/mL at Screening. For HBV-DNA- subjects (Cohorts E, F, I and J) only: HBV-DNA must be lower than the limit of quantitation at Screening.

Exclusion Criteria

Exclusion Criteria for Study Part 3
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. 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 greater than 2 × upper limit of normal (ULN).
- Total bilirubin greater than 1.5 × ULN.
- Alpha fetoprotein (AFP) greater than 100 ng/mL.

Study & Design

• Study Type: Interventional
• Study Design: Not specified