Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the safety and tolerability of REGN15160 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs). The secondary objectives of the study are: To assess the concentration-time profile of REGN15160 in serum To assess the immunogenicity of REGN15160

Official Title
-----------------
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: REGN15160 (IV)
* Drug: Matching Placebo (IV)
* Drug: REGN15160 (SC)
* Drug: Matching Placebo (SC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Has a SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization using a local reverse transcription polymerase chain reaction (RT-PCR) test or other molecular diagnostic assay and sample collection following assay standards Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening Has a body mass index (BMI) between 18 and 31 kg/m2 (inclusive) at the screening visit Is judged by the investigator to be in good health based on medical history, as defined in the protocol Is in good health based on laboratory safety testing obtained at the screening visit Key Exclusion Criteria: History of clinically significant disease and any concern, as defined in the protocol and as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit Has history of alcohol or drug abuse as determined by the investigator Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food Use of any prescription and non-prescription medications or nutritional supplements within approximately 5 half-lives or 2 weeks, whichever is longer, prior to first administration of the study drug through the end of the study, except for the permitted medications listed Participated in any clinical research study evaluating another investigational drug including biologics or therapy, including specific immunotherapy, within at least 5 half-lives or 90 days (whichever is longer) of an investigational biologic drug, or at least 4 weeks for small molecules or other investigational drugs, prior to the screening visit Is a pregnant or breastfeeding woman Is a woman of childbearing potential (WOCBP)1 who is unwilling to practice highly effective contraception (as defined in the protocol) prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after study drug administration NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lower IV Dose<br>Randomized 3:1 | Drug: REGN15160 (IV)<br>* Administered in single intravenous (IV) dose<br>Drug: Matching Placebo (IV)<br>* Administered in single IV dose<br>|
| Experimental: Mid IV Dose 1<br>Randomized 3:1 | Drug: REGN15160 (IV)<br>* Administered in single intravenous (IV) dose<br>Drug: Matching Placebo (IV)<br>* Administered in single IV dose<br>|
| Experimental: Mid IV Dose 2<br>Randomized 3:1 | Drug: REGN15160 (IV)<br>* Administered in single intravenous (IV) dose<br>Drug: Matching Placebo (IV)<br>* Administered in single IV dose<br>|
| Experimental: Higher IV Dose<br>Randomized 3:1 | Drug: REGN15160 (IV)<br>* Administered in single intravenous (IV) dose<br>Drug: Matching Placebo (IV)<br>* Administered in single IV dose<br>|
| Experimental: Lower SC Dose<br>Randomized 3:1 | Drug: REGN15160 (SC)<br>* Administered in single subcutaneous (SC) dose<br>Drug: Matching Placebo (SC)<br>* Administered in single SC dose<br>|
| Experimental: Mid SC Dose<br>Randomized 3:1 | Drug: REGN15160 (SC)<br>* Administered in single subcutaneous (SC) dose<br>Drug: Matching Placebo (SC)<br>* Administered in single SC dose<br>|
| Experimental: Higher SC Dose<br>Randomized 3:1 | Drug: REGN15160 (SC)<br>* Administered in single subcutaneous (SC) dose<br>Drug: Matching Placebo (SC)<br>* Administered in single SC dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and severity of all treatment emergent adverse events (TEAEs) |  | Through Day 169 | 
| Occurrence and severity of all serious adverse events (SAEs) |  | Through Day 169 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of REGN15160 in serum |  | Through Day 169 | 
| Incidence and titer of anti-drug antibodies (ADA) to REGN15160 |  | Through Day 169 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccinated, Negative SARS-CoV2 Test Result