Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy Volunteers

Study Overview
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Brief Summary
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This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.

Official Title
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A Randomized,Double-Blind,Placebo-Controlled,Ascending,Single-Dose Study of the Safety,Tolerability and Bioeffect of Intravenously Administered REGN727 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: REGN727
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 to 65 years of age. Weight> 50 kg and <95 kg inclusive For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day 1. For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant during the full duration of the study. Willing, committed, and able to return for all clinic visits and complete all study-related procedures. Able to read, understand and willing to sign the informed consent form. Exclusion Criteria: Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit. Pregnant or breast-feeding women. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study. Hospitalization for any reason within 60 days of screening. Known history of Human Immunodeficiency Virus (HIV) antibody; and/or positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit. Previous exposure to any therapeutic or investigational biological agent. History of alcohol or substance abuse within previous 5 years.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Dose 1 versus placebo | Drug: REGN727<br>* 5 IV cohorts (dose 1, 2, 3, 4, and 5)<br>Drug: Placebo<br>* 5 IV cohorts (dose 1, 2, 3, 4, and 5)<br>|
| Experimental: Cohort 2<br>Dose 2 versus placebo | Drug: REGN727<br>* 5 IV cohorts (dose 1, 2, 3, 4, and 5)<br>Drug: Placebo<br>* 5 IV cohorts (dose 1, 2, 3, 4, and 5)<br>|
| Experimental: cohort 3<br>Dose 3 versus placebo | Drug: REGN727<br>* 5 IV cohorts (dose 1, 2, 3, 4, and 5)<br>Drug: Placebo<br>* 5 IV cohorts (dose 1, 2, 3, 4, and 5)<br>|
| Experimental: cohort 4<br>Dose 4 versus placebo | Drug: REGN727<br>* 5 IV cohorts (dose 1, 2, 3, 4, and 5)<br>Drug: Placebo<br>* 5 IV cohorts (dose 1, 2, 3, 4, and 5)<br>|
| Experimental: cohort 5<br>Dose 5 versus placebo | Drug: REGN727<br>* 5 IV cohorts (dose 1, 2, 3, 4, and 5)<br>Drug: Placebo<br>* 5 IV cohorts (dose 1, 2, 3, 4, and 5)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106. |  | 106 days |