A Study of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and females

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: REGN3500
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index</= 33 kg/m2 In good health based on medical history, physical examination, vital signs, and laboratory testing Normal electrocardiogram (ECG) and blood pressure Able to comply with clinic visits and study-related procedures Able to sign an informed consent Exclusion Criteria: Significant abnormalities in hematology, clinical chemistry, urinalysis, medical history Current smoker or recent history (within 3 months) History of tuberculosis, HIV, or hepatic disease Known sensitivity to doxycycline or other ingredients of study drug History of multiple/severe allergies Pregnant or breastfeeding women, or not currently using adequate contraception Participation in another investigational drug study within 4 weeks

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Dose regimen 1 of REGN3500 (IV) versus placebo | Drug: REGN3500<br> <br> Drug: Placebo<br> <br> |
| Experimental: Cohort 2<br>Dose regimen 2 of REGN3500 (IV) versus placebo | Drug: REGN3500<br> <br> Drug: Placebo<br> <br> |
| Experimental: Cohort 3<br>Dose regimen 3 of REGN3500 (IV) versus placebo | Drug: REGN3500<br> <br> Drug: Placebo<br> <br> |
| Experimental: Cohort 4<br>Dose regimen 4 of REGN3500 (SC) versus placebo | Drug: REGN3500<br> <br> Drug: Placebo<br> <br> |
| Experimental: Cohort 5<br>Dose regimen 5 of REGN3500 (IV) versus placebo | Drug: REGN3500<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500 |  | Up to 293 days after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obtain the pharmacokinetic parameters (Cmax) that describe the serum concentration time profile of REGN3500 |  | Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing | 
| Obtain the pharmacokinetic parameters (Tmax) that describe the serum concentration time profile of REGN3500 |  | Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing | 
| Obtain the pharmacokinetic parameters (AUClast) that describe the serum concentration time profile of REGN3500 |  | Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Tolerability, Pharmacokinetics, REGN3500