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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Biological: REGN475 (SAR164877)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort 1<br>Dose 1 REGN475 | Biological: REGN475 (SAR164877)<br>* Subcutaneous administration REGN475 (SAR164877)<br>|
| Active Comparator: Cohort 2<br>Dose 2 of REGN475 | Biological: REGN475 (SAR164877)<br>* Subcutaneous administration REGN475 (SAR164877)<br>|
| Active Comparator: Cohort 3<br>Dose 2 of REGN475 | Biological: REGN475 (SAR164877)<br>* Subcutaneous administration REGN475 (SAR164877)<br>|
| Active Comparator: Cohort 4<br>Dose 1 of REGN475 | Biological: REGN475 (SAR164877)<br>* Subcutaneous administration REGN475 (SAR164877)<br>|
| Active Comparator: Cohort 5<br>Dose 2 of REGN475 | Biological: REGN475 (SAR164877)<br>* Subcutaneous administration REGN475 (SAR164877)<br>|
| Active Comparator: Cohort 6<br>Dose 1 REGN475 subcutaneous administration | Biological: REGN475 (SAR164877)<br>* Subcutaneous administration REGN475 (SAR164877)<br>|
| Active Comparator: Cohort 7<br>Dose 2 REGN475 subcutaneous administration | Biological: REGN475 (SAR164877)<br>* Subcutaneous administration REGN475 (SAR164877)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations of REGN475. |  | 16 Weeks | 
| The presence or absence of antibodies against REGN475. |  | 16 Week follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers