Safety and Tolerability Study of ARC-520 in Healthy Volunteers

Arrowhead Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: ARC-520

Study type: Interventional

Funder types: Industry

Identifiers

NCT01872065

Heparc-1001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.

Enrollment: 54 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Healthy male or female subjects, 18-55 years of age
• Be a non-smoker

Key Exclusion Criteria:

• History of clinically relevant medical illnesses that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
• Acute signs of hepatitis/other infection (e.g., moderate fever, jaundice, nausea, vomiting, abdominal pain) evident within 4 weeks of screening and/or at the screening examination.
• Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of study treatment.
• Is sero-positive for HIV, HBV, HCV, and/or a history of delta virus hepatitis.
• Currently uses and/or has a history of alcohol and/or drug abuse < 12 months from screening.
• Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

ARC-520

Experimental group

Description:

Single dose, intravenous administration of ARC-520.

Treatment:

Drug: ARC-520

Normal Saline

Placebo Comparator group

Description:

Single dose, intravenous administration of Normal Saline

Treatment:

Drug: Placebo