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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00856310

Enrollment

Registered

2009-03-05

Start date

2009-02-28

Completion date

2009-11-30

Last updated

2012-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteers

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.

Interventions

BIOLOGICALREGN475 (SAR164877)

Subcutaneous administration REGN475 (SAR164877)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026