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
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Feb 2009
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 12, 2009
CompletedFirst Posted
Study publicly available on registry
March 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedMay 10, 2012
May 1, 2012
9 months
February 12, 2009
May 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo.
16 weeks
Secondary Outcomes (2)
Serum concentrations of REGN475.
16 Weeks
The presence or absence of antibodies against REGN475.
16 Week follow up
Study Arms (7)
Cohort 1
ACTIVE COMPARATORDose 1 REGN475
Cohort 2
ACTIVE COMPARATORDose 2 of REGN475
Cohort 3
ACTIVE COMPARATORDose 2 of REGN475
Cohort 4
ACTIVE COMPARATORDose 1 of REGN475
Cohort 5
ACTIVE COMPARATORDose 2 of REGN475
Cohort 6
ACTIVE COMPARATORDose 1 REGN475 subcutaneous administration
Cohort 7
ACTIVE COMPARATORDose 2 REGN475 subcutaneous administration
Interventions
Subcutaneous administration REGN475 (SAR164877)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (1)
Unknown Facility
Altoona, Pennsylvania, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2009
First Posted
March 5, 2009
Study Start
February 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
May 10, 2012
Record last verified: 2012-05