Status:
COMPLETED
A Single-Dose Study of the Safety and Tolerability of REGN475(SAR164877) in Healthy Subjects
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Healthy
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled single-dose study of the safety and tolerability of intravenously administered REGN475 in healthy volunteers. The primary objective of the study ...
Eligibility Criteria
Inclusion
- Key
- Male or female volunteers, in general good health and 21 to 65 years of age.
- Female volunteers must be post-menopausal for at least 1 year or surgically sterile.
- Key
Exclusion
- Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, GI, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/ PK data
- Participation in any clinical research study evaluating another investigational drug or therapy within 3 weeks or at least 5 half-lives of the investigational drug, whichever is longer, prior to the Screening Visit.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00856310
Start Date
February 1 2009
End Date
November 1 2009
Last Update
May 10 2012
Active Locations (1)
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1
Altoona, Pennsylvania, United States