A Study of AB-161 Following Oral Administration in Healthy Subjects

Phase 1

• Conditions: Hepatitis B; Infection - Other infectious diseases

• Registration Number: ACTRN12623000074695
• Lead Sponsor: Arbutus Biopharma Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-23
• Study Completion: 2023-05-10
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Subject must be 18 (or other appropriate age of consent) to 50 years of age, inclusive, at the time of signing the informed consent. Healthy subjects are defined as individuals free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results.

2. Body mass index (BMI) more than 18 kg per meter square and less than 35 kg per meter square.

3. A male subject is eligible to participate if he does not have a female partner who is pregnant or who intends to become pregnant during the study. Male subjects must agree to use contraception as outlined in the protocol.

4. A female subject is eligible to participate only if she is a NOT a women of childbearing potential (WOCBP).

5. Ability to review and capable of giving signed informed consent which includes compliance with all protocol-specified visit schedules and requirements

Exclusion Criteria

1. A history of clinically significant endocrine, gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, cardiovascular, psychiatric or neurologic disorders.

2. Clinically significant ECG abnormalities, blood pressure or laboratory abnormalities, confirmed by repeat.

3. Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV confirmed by polymerase chain reaction (PCR). Evidence of prior HBV vaccination (positive HbsAb) is not exclusionary, and subjects with documented resolved HBV infection (HBsAg and HBV DNA negative) may participate.

4. Subjects who smoke or meet the protocol criteria for substance abuse.

5. Subjects who are unwilling to comply with protocol contraception requirements, and female subjects who are WOCBP, pregnant or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified