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 Corporation0 个研究点目标入组 28 人开始时间: 2019年9月11日最近更新: 2019年11月25日

研究概览

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•To be eligible for enrolment into this study, subjects must meet all of the inclusion criteria for cohort in which they are enrolled:
•1.Healthy males or females aged 18–45, inclusive.
•2.Subjects must be either White/Caucasian or East Asian
•3.Male subjects must agree to use contraception as detailed in the protocol.
•4.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.
•5.Body mass index (BMI) greater than or equal to 18 kg/m2 and less than or equal to 28 kg/m2.
•6.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.

•To be eligible for enrolment into this study, subjects must not meet any of the exclusion criteria for the cohort in which they are enrolled:
•Medical Status or History;
•1.A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, or cardiovascular disease.
•2.Evidence of active or suspected malignancy, or a history of malignancy.
•Findings/Diagnostic Assessments;
•1.Clinically significant ECG or Vital Signs abnormalities at Screening, Day -1, or Day 1 pre-dose
•2.Clinically significant abnormalities in laboratory test results at Screening or Day -1
•3.ALT or AST > upper limit of normal (ULN) confirmed by a repeat reading.
•4.Estimated creatinine clearance <80 mL/min
•5.Positive serology for HBV, hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
•6. 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.

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