CompletedPhase 1ACTRN12619000954123

A Study to Investigate the Safety, Tolerability and Pharmacokinetics, of AB-729 Administered by Subcutaneous Injection to Healthy Subjects (part 1)

Part 1 of a three part study- A Study to Investigate the Safety, Tolerability and Pharmacokinetics, of AB-729 Administered by Subcutaneous Injection to Healthy Subjects (part 1)

Sponsor

Arbutus Biopharma Corporation

Enrollment

24 participants

Start Date

Jul 16, 2019

Study Type

Interventional

Conditions

Chronic Hepatitis B Infection

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 1 will be a blinded, single ascending dose (SAD) design and will be conducted in 24 healthy subjects.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria4

Adult male or female subjects aged 18 to 45 years
Male subjects must agree to use contraception as detailed in the protocol.
Healthy males or females aged 18 to 45, inclusive. Female subjects may not be of childbearing potential (surgically sterile or post-menopausal).
Body mass index (BMI) greater than or equal to 18 kg/m2 and lesser than or equal to 32 kg/m2.

Exclusion Criteria8

Medical Status or History:
A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary,
neurological, psychiatric, cardiovascular disease, or evidence of active or suspected malignancy, or a
history of malignancy.
Findings/Diagnostic Assessments
Clinically significant ECG abnormalities or vital sign abnormalities at Screening, Day -1, or Day 1 predose
Clinically significant abnormalities in laboratory test results at Screening or Day -1, that are confirmed by a repeat reading.
Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV), hepatitis A virus (HAV)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The study will be conducted in 3 parts. Part 1 will be a blinded, single ascending dose (SAD) design and will be conducted in 24 healthy subjects. Part 1: Subjects will receive single ascending do

The study will be conducted in 3 parts. Part 1 will be a blinded, single ascending dose (SAD) design and will be conducted in 24 healthy subjects. Part 1: Subjects will receive single ascending doses consisting of 4 sequential dose groups and this part will be approximately 8 weeks. Approximately 24 healthy subjects will enroll in Part 1. Subjects will receive AB-729 or placebo administered Subcutaneous (SC) injection. The starting dose will be 60 mg. Subsequent doses in Part 1 will be confirmed after review of safety and tolerability from prior dose levels. Each participant will receive a single dose of AB-729 or placebo only. All doses of AB-729 will be administered at the study site by study staff members. Frequency/duration of each dose: Single dose study for Part 1