Overview

A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)

Status:
Terminated
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
Normal healthy volunteer (NHV) participants will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 Injection or placebo. The maximum study duration for NHVs is approximately 21 weeks. Hepatitis B e Antigen (HBeAg)-negative participants with (CHB) will enroll sequentially into 3 dose levels (8 patients per dose level) to receive multiple doses of open label ARC-521 Injection. For each CHB participant the maximum study duration is approximately 37 weeks.
Phase:
Phase 1
Details
Lead Sponsor:
Arrowhead Pharmaceuticals
Treatments:
Acetaminophen
Entecavir
Histamine Antagonists
Histamine H1 Antagonists
Tenofovir