Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers

Study Overview
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Brief Summary
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This study is being conducted to assess the safety and tolerability of a single ascending intravenous (IV) dose of REGN846 in healthy volunteers.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety and Tolerability of Intravenously Administered REGN846 (SAR302352) in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Biological: REGN846


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, inclusive Normal vital signs after resting in a sitting position for 5 minutes: Normal standard 12-lead ECG Willing and able to comply with clinic visits and study-related procedures Provide signed informed consent Able to understand and complete study-related questionnaires Exclusion Criteria: Current or prior history of smoking Any illness or condition that would adversely affect the subject's participation in this study Hospitalization within 60 days of the screening visit Any clinically significant abnormalities observed during the screening visit History of or positive human immunodeficiency virus (HIV) screen result at the screening visit History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit History of positive drug screen result for drug or alcohol abuse within a year prior to the screening visit Known sensitivity to any of the components of the Investigational Product formulation Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit Any condition that would place the subject at risk, interfere with participation in the study History of a parasitic infection or recent (within the previous 6 months) travel to a parasitic endemic area Live/attenuated vaccinations within 12 weeks of screening or during the study Any subjects with planned elective surgery Sexually active men who are unwilling to utilize adequate contraception

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br>(3:1, active: placebo) | Biological: REGN846<br>* 5 IV cohorts (Dose 1, 2, 3, 4, 5)<br>|
| Experimental: Dose 2<br>(3:1, active: placebo) | Biological: REGN846<br>* 5 IV cohorts (Dose 1, 2, 3, 4, 5)<br>|
| Experimental: Dose 3<br>(3:1, active: placebo) | Biological: REGN846<br>* 5 IV cohorts (Dose 1, 2, 3, 4, 5)<br>|
| Experimental: Dose 4<br>(3:1, active: placebo) | Biological: REGN846<br>* 5 IV cohorts (Dose 1, 2, 3, 4, 5)<br>|
| Experimental: Dose 5<br>(3:1, active: placebo) | Biological: REGN846<br>* 5 IV cohorts (Dose 1, 2, 3, 4, 5)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events |  | Baseline through end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile |  | Baseline through end of study | 
| Immunogenicity |  | Visits 2, 8, 10 and 12 |