Study of the Blood Concentrations of Two Formulations of REGN1033 in Healthy Subjects

Study Overview
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Brief Summary
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Primary Objective: Determine blood concentrations of two formulations of REGN1033. Secondary Objective: Assess safety and tolerability of REGN1033.

Official Title
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A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of REGN1033 Produced From Two Different Cell Lines in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: REGN1033


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Healthy males and females (not of childbearing potential) between the ages of 18 and 65 years Body weight between 50.0 kg and 95.0 kg Willing and able to comply with clinic visits and study-related procedures Provide signed informed consent Key Exclusion Criteria: Donation or loss of approximately 400 mL or more of blood within 8 weeks prior to dosing, or plasma up to 14 days prior to dosing Hemoglobin not within normal limits Positive drug and alcohol screen test results at screening visits 1 and 2 Low or elevated blood pressure and/or heart rate after 3 minutes resting in the seated position: Recent use (within 3 months prior to screening) of androgenic steroids Participation in any clinical research study that evaluated 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 Previous exposure to any biological therapeutic agent, except vaccines Known sensitivity to tamoxifen, doxycycline, or similar compounds (ie, tetracyclines) Pregnant or breastfeeding women, and women of childbearing potential Sexually active men who are unwilling to practice adequate contraception during the study

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reference Drug<br>REGN1033 Reference Formulation | Drug: REGN1033<br> <br> |
| Experimental: Test Drug<br>REGN1033 Test Formulation | Drug: REGN1033<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum REGN1033 concentration-time curve (AUC) |  | Pre-dose to day 57 | 
| Peak REGN1033 concentration (Cmax) |  | Pre-dose to day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent adverse events (TEAEs) from baseline to the end of the study |  | Day 1 to end of study (Day 57) | 
| Presence or absence of anti-drug antibody (ADA) |  | Day 1 to end of study (Day 57) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood, Drug concentration, REGN1033