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

PHASE1TerminatedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

November 30, 2016

Study Completion Date

November 30, 2016

Conditions
Hepatitis B
Interventions
DRUG

ARC-521 Injection

OTHER

Placebo

0.9% normal saline

DRUG

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.

DRUG

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).

DRUG

entecavir

Participants take entecavir OR tenofovir daily throughout the study.

DRUG

tenofovir

Participants take entecavir OR tenofovir daily throughout the study.

Trial Locations (1)

1011

Auckland Clinical Studies Ltd, Grafton

Sponsors
All Listed Sponsors
lead

Arrowhead Pharmaceuticals

INDUSTRY