Study of ARB-001467 in Subjects With Chronic HBV Infection Receiving Nucleos(t)Ide Analogue Therapy

• Status: Completed
• Trial end date: 2018-05-18
• Target enrollment: 0
• Participant gender: All

Summary

The study is a phase 2a, single blind, randomized, placebo controlled, study evaluating the safety, anti-viral activity, and pharmacokinetics (PK) following multiple doses of intravenous ARB-001467

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbutus Biopharma Corporation

Criteria

Key Inclusion Criteria:

• Documented chronic HBV infection for ≥12 months prior to Screening Visit.

• Quantitative HBsAg ≥1000 IU/mL at the Screening Visit.

• Subjects currently receiving entecavir and/or tenofovir for ≥12 months and HBV DNA undetectable.

Key Exclusion Criteria:

• Known co-infection with HIV, hepatitis C virus, and hepatitis D virus.

• Receiving or planning to receive systemic immunosuppressive medications during the study or ≤2 months prior to the first dose of study treatment.

• Receiving or planning to receive interferon during the study or ≤12 months prior to the first dose of study treatment.

• Significant immunosuppression from, but not limited to immunodeficiency conditions such as common variable hypogammaglobulinemia.

• Clinical diagnosis of substance abuse with alcohol, narcotics, or cocaine ≤12 months prior to the Screening Visit.

• Any known pre-existing medical or psychiatric condition that could interfere with the subject's ability to provide informed consent or participate in study conduct, or that may confound study findings.