Trial | NCT01872065  Report issue

Title

Safety and Tolerability Study of ARC-520 in Healthy Volunteers
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 in Normal Adult Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    arc-520 ...

  • Study Participants

    54
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.
Study Started
Jul 31
2013
Primary Completion
Sep 30
2014
Study Completion
Nov 30
2014
Last Update
Dec 10
2014
Estimate

Drug ARC-520

Drug Placebo

ARC-520 Experimental

Single dose, intravenous administration of ARC-520.

Normal Saline Placebo Comparator

Single dose, intravenous administration of Normal Saline

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.
No Results Posted