Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers

Study Overview
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Brief Summary
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This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: REGN2009
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women ages 18 to 65 years inclusive Body mass index between 18.0 kg/m^2 and 30.0 kg/m^2, inclusive Exclusion Criteria: Pregnant or breast-feeding women Any clinically significant abnormalities observed during screening (day -21 to day -2) 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 History of drug or alcohol abuse within a year prior to the screening visit (day -21 to day -2) Hospitalization for any reason within 60 days of the screening visit (day -21 to day -2) Participation in any clinical research study within 30 days of the screening visit (day -21 to day -2) or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer) History of a hypersensitivity reaction to doxycycline or similar compound Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results Previous adverse experience to any biological investigational or therapeutic agent Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REGN2009 dose level 1<br>Cohort A - REGN2009 or placebo; Cohort B - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo) | Drug: REGN2009<br> <br> Other: placebo<br> <br> |
| Experimental: REGN2009 dose level 2<br>Cohort C - REGN2009 or placebo; Cohort D - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo) | Drug: REGN2009<br> <br> Other: placebo<br> <br> |
| Experimental: REGN2009 dose level 3<br>Cohort E - REGN2009 or placebo; Cohort F - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo) | Drug: REGN2009<br> <br> Other: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of TEAEs | The primary endpoint in this study is the incidence and severity of Treatment Emergent Adverse Events (TEAEs) in healthy volunteers treated with REGN2009 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 15. | day 1 to day 106/ visit 15 |