Status:
COMPLETED
Safety and Tolerability Study of ARC-520 in Healthy Volunteers
Lead Sponsor:
Arrowhead Pharmaceuticals
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.
Eligibility Criteria
Inclusion
- Key
- Healthy male or female subjects, 18-55 years of age
- Be a non-smoker
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01872065
Start Date
July 1 2013
End Date
November 1 2014
Last Update
December 26 2025
Active Locations (1)
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1
Research Site 1
Melbourne, Victoria, Australia, 3004