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

May 9, 2012 updated by: Regeneron Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo.
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum concentrations of REGN475.
Time Frame: 16 Weeks
16 Weeks
The presence or absence of antibodies against REGN475.
Time Frame: 16 Week follow up
16 Week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (Estimate)

March 5, 2009

Study Record Updates

Last Update Posted (Estimate)

May 10, 2012

Last Update Submitted That Met QC Criteria

May 9, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R475-PN-0817

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on REGN475 (SAR164877)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe