A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the safety and tolerability of REGN14284 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 REGN14284 in serum To assess the immunogenicity of REGN14284

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Regeneron Anti-SARS-CoV-2 Monoclonal Antibody (a COVID-19 Therapeutic) in Adult Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: REGN14284
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Has SARS-CoV-2-negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol. 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, physical examination, vital sign measurements, laboratory safety testing and ECGs performed at screening and/or prior to administration of study drug Key Exclusion Criteria: History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, infectious, autoimmune, oncologic, psychiatric or neurological disease, as assessed by the investigator as described in the protocol Presents any concern to the investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit Has a history of alcohol or drug abuse as determined by the investigator Has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction to drugs or food as described in the protocol Use of any 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 as described in the protocol Participated in any clinical research study evaluating another investigational drug including biologics or 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 NOTE: Other protocol defined inclusion / exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 Mid IV Dose<br>Randomized 3:1 for single ascending dose | Drug: REGN14284<br>* Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol<br>Drug: Matching Placebo<br>* Single ascending IV or SC administration per the protocol<br>|
| Experimental: Cohort 2 Mid SC Dose<br>Randomized 3:1 for single ascending dose | Drug: REGN14284<br>* Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol<br>Drug: Matching Placebo<br>* Single ascending IV or SC administration per the protocol<br>|
| Experimental: Cohort 3 High IV Dose<br>Randomized 3:1 for single ascending dose | Drug: REGN14284<br>* Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol<br>Drug: Matching Placebo<br>* Single ascending IV or SC administration per the protocol<br>|
| Experimental: Cohort 4 High SC Dose<br>Randomized 3:1 for single ascending dose | Drug: REGN14284<br>* Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol<br>Drug: Matching Placebo<br>* Single ascending IV or SC administration per the protocol<br>|
| Experimental: Cohort 5 Higher IV Dose<br>Randomized 3:1 for single ascending dose | Drug: REGN14284<br>* Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol<br>Drug: Matching Placebo<br>* Single ascending IV or SC administration per the protocol<br>|
| Experimental: Cohort 6 Highest IV Dose<br>Randomized 3:1 for single ascending dose | Drug: REGN14284<br>* Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol<br>Drug: Matching Placebo<br>* Single ascending IV or SC administration per the protocol<br>|
| Experimental: Cohort 7 Low IV Dose<br>Randomized 3:1 for single ascending dose | Drug: REGN14284<br>* Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol<br>Drug: Matching Placebo<br>* Single ascending IV or SC administration per the protocol<br>|
| Experimental: Cohort 8 Low SC Dose<br>Randomized 3:1 for single ascending dose | Drug: REGN14284<br>* Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol<br>Drug: Matching Placebo<br>* Single ascending IV or SC administration per the protocol<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of REGN14284 in serum over time |  | Through approximately day 169 | 
| Incidence of Anti-drug antibodies (ADAs) to REGN14284 over time |  | Through approximately day 90 | 
| Titer of ADAs to REGN14284 over time |  | Through approximately day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus disease 2019 (COVID-19) vaccinated, Negative SARS-CoV-2 diagnostic test within approximately ≤72 hours of randomization