A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults

Study Overview
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Brief Summary
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The purpose of this study is to learn about the safety and tolerability of different doses of REGN17092 administered with a needle either under the skin (called subcutaneous) or into a vein (called an infusion) in healthy participants. This is the first time that REGN17092 will be given to people. Other aims are to assess: How much of the study drug is in the blood at different times Whether the body makes its own antibodies against the study drug (which could make the drug less effective or lead to side effects)

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN17092, an Anti-SARS-CoV-2 (COVID-19) Monoclonal Antibody, in Adult Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: REGN17092
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Has a 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/m^2 (inclusive) at the screening visit Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram (ECG)s performed at screening and/or prior to administration of initial dose 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 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 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 6:2 for single ascending dose | Drug: REGN17092<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 6:2 for single ascending dose | Drug: REGN17092<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 6:2 for single ascending dose | Drug: REGN17092<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 Low IV Dose<br>Randomized 6:2 for single ascending dose | Drug: REGN17092<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 6:2 for single ascending dose | Drug: REGN17092<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 6:2 for single ascending dose | Drug: REGN17092<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 SC Dose<br>Randomized 6:2 for single ascending dose | Drug: REGN17092<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: Expansion Cohort 1<br>Randomized 3:1 for single ascending dose | Drug: REGN17092<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: Expansion Cohort 2<br>Randomized 3:1 for single ascending dose | Drug: REGN17092<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: Expansion Cohort 3<br>Randomized 3:1 for single ascending dose | Drug: REGN17092<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 of all treatment emergent adverse events (TEAEs) |  | Through approximately day 365 | 
| Severity of all TEAEs |  | Through approximately day 365 | 
| Occurrence of all treatment emergent serious adverse events (TE-SAEs) |  | Through approximately day 365 | 
| Severity of all TE-SAEs |  | Through approximately day 365 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of REGN17092 in serum over time |  | Through approximately day 365 | 
| Incidence of Anti-drug antibodies (ADAs) to REGN17092 over time |  | Through approximately day 365 | 
| Titer of ADAs to REGN17092 over time |  | Through approximately day 365 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe acute respiratory syndrome coronavirus (SARS-CoV-19), Coronavirus disease 2019 (COVID-19) vaccinated, Omicron variant