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Completed

NCT Number: NCT00856310

A Single-Dose Study of the Safety and Tolerability of REGN475(SAR164877) 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.

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altoona, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REGN475 (SAR164877)

Biological

Subcutaneous administration REGN475 (SAR164877)

Primary outcomes

  1. Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo.

    Time frame: 16 weeks

Secondary outcomes

  1. Serum concentrations of REGN475.

    Time frame: 16 Weeks

  2. The presence or absence of antibodies against REGN475.

    Time frame: 16 Week follow up

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 5, 2009
Registry last updated
May 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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