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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:
ClinicalTrials.gov Identifier:
NCT00856310
First Posted: March 5, 2009
Last Update Posted: May 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
  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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, 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 ]

Secondary Outcome Measures:
  • Serum concentrations of REGN475. [ Time Frame: 16 Weeks ]
  • The presence or absence of antibodies against REGN475. [ Time Frame: 16 Week follow up ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00856310     History of Changes
Other Study ID Numbers: R475-PN-0817
First Submitted: February 12, 2009
First Posted: March 5, 2009
Last Update Posted: May 10, 2012
Last Verified: May 2012

Keywords provided by Regeneron Pharmaceuticals:
Healthy volunteers