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

Regeneron Pharmaceuticals0 sites56 target enrollmentFebruary 2009

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Regeneron Pharmaceuticals
Enrollment: 56
Primary Endpoint: Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

November 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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.