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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Biological: REGN475 (SAR164877)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Safety and Tolerability of REGN475 in Healthy Subjects

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 56
Study Start Date: February 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort 1
Dose 1 REGN475
 Biological: REGN475 (SAR164877)
Subcutaneous administration REGN475 (SAR164877)
Active Comparator: Cohort 2
Dose 2 of REGN475
 Biological: REGN475 (SAR164877)
Subcutaneous administration REGN475 (SAR164877)
Active Comparator: Cohort 3
Dose 2 of REGN475
 Biological: REGN475 (SAR164877)
Subcutaneous administration REGN475 (SAR164877)
Active Comparator: Cohort 4
Dose 1 of REGN475
 Biological: REGN475 (SAR164877)
Subcutaneous administration REGN475 (SAR164877)
Active Comparator: Cohort 5
Dose 2 of REGN475
 Biological: REGN475 (SAR164877)
Subcutaneous administration REGN475 (SAR164877)
Active Comparator: Cohort 6
Dose 1 REGN475 subcutaneous administration
 Biological: REGN475 (SAR164877)
Subcutaneous administration REGN475 (SAR164877)
Active Comparator: Cohort 7
Dose 2 REGN475 subcutaneous administration
 Biological: REGN475 (SAR164877)
Subcutaneous administration REGN475 (SAR164877)

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856310

Locations
United States, Pennsylvania
Altoona, Pennsylvania, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00856310     History of Changes
Other Study ID Numbers: R475-PN-0817
Study First Received: February 12, 2009
Last Updated: May 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Regeneron Pharmaceuticals:
Healthy volunteers

ClinicalTrials.gov processed this record on May 16, 2013