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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: REGN475 (SAR164877)

• Registration Number: NCT00856310
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-03-03
• Study First Posted: 2009-03-05
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-09
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	REGN475 (SAR164877)	Dose 1 REGN475
Cohort 4	REGN475 (SAR164877)	Dose 1 of REGN475
Cohort 5	REGN475 (SAR164877)	Dose 2 of REGN475
Cohort 2	REGN475 (SAR164877)	Dose 2 of REGN475
Cohort 3	REGN475 (SAR164877)	Dose 2 of REGN475
Cohort 6	REGN475 (SAR164877)	Dose 1 REGN475 subcutaneous administration
Cohort 7	REGN475 (SAR164877)	Dose 2 REGN475 subcutaneous administration

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo.	16 weeks

Secondary Outcome Measures

Name	Time	Method
Serum concentrations of REGN475.	16 Weeks
The presence or absence of antibodies against REGN475.	16 Week follow up