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

NCT ID: NCT00856310

Last Updated: 2012-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort 1

Dose 1 REGN475

Group Type ACTIVE_COMPARATOR

REGN475 (SAR164877)

Intervention Type BIOLOGICAL

Subcutaneous administration REGN475 (SAR164877)

Cohort 2

Dose 2 of REGN475

Group Type ACTIVE_COMPARATOR

REGN475 (SAR164877)

Intervention Type BIOLOGICAL

Subcutaneous administration REGN475 (SAR164877)

Cohort 3

Dose 2 of REGN475

Group Type ACTIVE_COMPARATOR

REGN475 (SAR164877)

Intervention Type BIOLOGICAL

Subcutaneous administration REGN475 (SAR164877)

Cohort 4

Dose 1 of REGN475

Group Type ACTIVE_COMPARATOR

REGN475 (SAR164877)

Intervention Type BIOLOGICAL

Subcutaneous administration REGN475 (SAR164877)

Cohort 5

Dose 2 of REGN475

Group Type ACTIVE_COMPARATOR

REGN475 (SAR164877)

Intervention Type BIOLOGICAL

Subcutaneous administration REGN475 (SAR164877)

Cohort 6

Dose 1 REGN475 subcutaneous administration

Group Type ACTIVE_COMPARATOR

REGN475 (SAR164877)

Intervention Type BIOLOGICAL

Subcutaneous administration REGN475 (SAR164877)

Cohort 7

Dose 2 REGN475 subcutaneous administration

Group Type ACTIVE_COMPARATOR

REGN475 (SAR164877)

Intervention Type BIOLOGICAL

Subcutaneous administration REGN475 (SAR164877)

Interventions

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REGN475 (SAR164877)

Subcutaneous administration REGN475 (SAR164877)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Altoona, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R475-PN-0817

Identifier Type: -

Identifier Source: org_study_id

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