47
Participants
Start Date
June 30, 2016
Primary Completion Date
November 30, 2016
Study Completion Date
November 30, 2016
ARC-521 Injection
Placebo
0.9% normal saline
antihistamine
Approximately two hours prior to ARC-521 or placebo administration, participants will be pre-treated with an oral antihistamine, selected by the investigator from the list of approved antihistamines that is available in that country. Approved antihistamines are: diphenhydramine 50 mg by mouth (PO), chlorpheniramine 8 mg PO, or hydroxyzine 50 mg PO.
acetaminophen
Approximately two hours prior to ARC-521 or placebo administration, participants will be pre-treated with acetaminophen (500 - 1000 mg PO, per local strength availability).
entecavir
Participants take entecavir OR tenofovir daily throughout the study.
tenofovir
Participants take entecavir OR tenofovir daily throughout the study.
Auckland Clinical Studies Ltd, Grafton
Lead Sponsor
Arrowhead Pharmaceuticals
INDUSTRY