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A Single-Dose Study of the Safety and Tolerability of REGN475(SAR164877) in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00856310
First received: February 12, 2009
Last updated: May 9, 2012
Last verified: May 2012

February 12, 2009
May 9, 2012
February 2009
November 2009   (final data collection date for primary outcome measure)
Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00856310 on ClinicalTrials.gov Archive Site
  • Serum concentrations of REGN475. [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
  • The presence or absence of antibodies against REGN475. [ Time Frame: 16 Week follow up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Single-Dose Study of the Safety and Tolerability of REGN475(SAR164877) in Healthy Subjects
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Safety and Tolerability of REGN475 in Healthy Subjects

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 is to assess the safety and tolerability of REGN475. The secondary objectives are to characterize the pharmacokinetic and immunogenicity profiles of REGN475.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
Biological: REGN475 (SAR164877)
Subcutaneous administration REGN475 (SAR164877)
  • Active Comparator: Cohort 1
    Dose 1 REGN475
    Intervention: Biological: REGN475 (SAR164877)
  • Active Comparator: Cohort 2
    Dose 2 of REGN475
    Intervention: Biological: REGN475 (SAR164877)
  • Active Comparator: Cohort 3
    Dose 2 of REGN475
    Intervention: Biological: REGN475 (SAR164877)
  • Active Comparator: Cohort 4
    Dose 1 of REGN475
    Intervention: Biological: REGN475 (SAR164877)
  • Active Comparator: Cohort 5
    Dose 2 of REGN475
    Intervention: Biological: REGN475 (SAR164877)
  • Active Comparator: Cohort 6
    Dose 1 REGN475 subcutaneous administration
    Intervention: Biological: REGN475 (SAR164877)
  • Active Comparator: Cohort 7
    Dose 2 REGN475 subcutaneous administration
    Intervention: Biological: REGN475 (SAR164877)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
November 2009
November 2009   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00856310
R475-PN-0817
No
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP