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

Tracking Information

First Received Date ^ICMJE

February 12, 2009

Last Updated Date

May 9, 2012

Start Date ^ICMJE

February 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00856310 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Safety and Tolerability of REGN475 in Healthy Subjects

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Biological: REGN475 (SAR164877)

Subcutaneous administration REGN475 (SAR164877)

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

21 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00856310

Other Study ID Numbers ^ICMJE

R475-PN-0817

Has Data Monitoring Committee

Responsible Party

Regeneron Pharmaceuticals

Study Sponsor ^ICMJE

Regeneron Pharmaceuticals

Collaborators ^ICMJE

Sanofi

Investigators ^ICMJE

Study Director:

Clinical Trial Management

Regeneron Pharmaceuticals

Information Provided By

Regeneron Pharmaceuticals

Verification Date

May 2012

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

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