Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-836 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arbutus Biopharma Corporation
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• Healthy Subjects

1. Male subjects or female subjects not of childbearing potential between 18 and 45 years old.

2. Free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results.

3. BMI of 18-32 kg/m2.

• CHB Subjects:

1. Male or female between 18 and 65 years old.

2. Chronic HBV infection documented as a positive HBsAg, HBV DNA, or HBeAg test at least 6 months prior to the Screening Visit, or a historical liver biopsy consistent with chronic HBV infection

3. For cohort F, G, H and J:

1. HBV DNA ≥2,000 IU/mL at Screening (subjects may be either treatment-naïve or treatment-experienced but currently off-treatment).

2. ALT ≤ 5x ULN

4. For Cohort I:

1. HBV DNA2. Subjects must have been receiving either TAF, TDF, or ETV consistently for ≥6 months prior to Day 1 and are willing to continue with the same NA treatment through the final study visit.

3. ALT ≤ 2.5 x ULN

5. HbsAg ≥250 IU/mL at screening

Exclusion Criteria:

• CHB Subjects

1. Advanced fibrosis, cirrhosis or other signs of advanced liver disease as assessed by clinical history, ultrasound or FibroScan, or history of cirrhosis or any clinically significant medical condition associated with chronic liver disease.

2. Co-infection with HIV or other non-B hepatitis viruses.

3. Any clinically significant or unstable medical condition or illness that could confound study findings.

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

5. Previous treatment with a capsid inhibitor, core inhibitor, or core protein assembly modifier [CpAM or CAM]) within 6 months of the Day 1 visit, or prior treatment with an HBV-targeted siRNA or antisense oligonucleotide compound at any time.