A study to evaluate the Safety, Tolerability, and Pharmacokinetics of AB-506 in Healthy Subjects for 28 Days
A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AB-506, an HBV Capsid Inhibitor, in Healthy Caucasian and East Asian Subjects for 28 Days
Arbutus Biopharma Corporation
28 participants
Sep 11, 2019
Interventional
Conditions
Summary
This is a Phase 1, double blind, randomized, placebo-controlled, multiple dose study to investigate the safety, tolerability, and PK of orally administered multiple doses of AB-506 to healthy subjects for 28 days. The purpose of this study will be to explore the safety, tolerability, and PK of multiple doses of AB-506 in Caucasian and East Asian healthy subjects for 28 days.
Eligibility
Inclusion Criteria8
- Healthy males or females aged 18–45, inclusive.
- Subjects must be either White/Caucasian or East Asian
- Male subjects must agree to use contraception as detailed in the protocol.
- A female subject is eligible to participate if she is not pregnant, not breastfeeding, does not intend to become pregnant during the study, and at least one of the following conditions applies:
- a. Not a woman of childbearing potential OR
- b. A woman of childbearing potential who agrees to follow the contraceptive guidance starting 4 weeks prior to the first dose of study drug, during the treatment period, and for 30 days after the last dose of study treatment.
- Body mass index (BMI) greater than or equal to 18 kg/m2 and less than or equal to 28 kg/m2.
- Capable of giving signed informed consent, able to understand and comply with protocol requirements, instructions, and protocol-related restrictions, and likely to complete the study as planned.
Exclusion Criteria13
- Medical Status or History;
- A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, or cardiovascular disease.
- Evidence of active or suspected malignancy, or a history of malignancy.
- Findings/Diagnostic Assessments;
- Clinically significant ECG or Vital Signs abnormalities at Screening, Day -1, or Day 1 pre-dose
- Clinically significant abnormalities in laboratory test results at Screening or Day -1
- ALT or AST > upper limit of normal (ULN) confirmed by a repeat reading.
- Estimated creatinine clearance <80 mL/min
- Positive serology for HBV, hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Subjects meeting any of the following criteria for substance abuse potential:
- a. Subjects with a clinical history of or current heavy drinking.
- b. Positive alcohol test (breath, saliva, or urine) at Screening or Day -1.
- c. Positive urine test for drugs of abuse at Screening or Day -1.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
This study will be a Phase 1, double blind, randomized, placebo-controlled, multiple dose study to investigate the safety, tolerability, and PK of orally administered multiple doses of AB-506 to healthy subjects for 28 days. Two unique cohorts of 14 healthy subjects, one Caucasian (Cohort A) and one East Asian (Cohort B): AB-506 or placebo will be administered once daily (10:4 ratio AB-506:placebo) for 28 days. Each subject will participate in a screening visit and will receive 400mg AB-506 orally once daily for 28 days, with follow-up visits 4, 7 and 14 days after last dose. Adherence to the intervention is monitored by instructing the subjects to bring all unused study medication containers to each treatment period visit, as well as any empty bottles. The dates and number of tablets dispensed and returned must be recorded on the drug accountability form maintained on-site. Subjects will be instructed to record their study drug dosing in a dosing diary, which will be reviewed at each visit, in combination with drug accountability to confirm treatment compliance. Sites should discuss with the subject if there are discrepancies between the diary and the drug log to reconcile actual dosing at each visit.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12619001255178