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

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ClinicalTrials.gov Identifier: NCT00856310
Recruitment Status : Completed
First Posted : March 5, 2009
Last Update Posted : May 10, 2012
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Healthy Biological: REGN475 (SAR164877) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo. [ Time Frame: 16 weeks ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older 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.

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

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

Keywords provided by Regeneron Pharmaceuticals:
Healthy volunteers