Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19

Study Overview
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Brief Summary
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The primary objectives are: To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration The secondary objectives are: To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration To assess the immunogenicity of REGN10933 and REGN10987

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers

Conditions
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Healthy, Chronic Stable Illness

Intervention / Treatment
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* Drug: REGN10933+REGN10987
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study Stable medication for co-morbid condition(s) for at least 6 months prior to screening Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission Key Exclusion Criteria: Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization Subject-reported clinical history of COVID-19 as determined by investigator Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19 Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations) in the past 6 months prior to screening Received investigational or approved SARS-CoV-2 vaccine Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol Use of remdesivir, intravenous immunoglobulin (IVIG), or other anti-SARS viral agents within 2 months prior to screening NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REGN10933+REGN10987<br> | Drug: REGN10933+REGN10987<br>* Administered subcutaneous (SC) every 4 weeks (Q4W)<br>* Other names: Ronapreve™;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Administered subcutaneous (SC) every 4 weeks (Q4W)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration |  | Within 4 days postdose at Baseline | 
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration |  | Within 4 days postdose at Day 29 | 
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration |  | Within 4 days postdose at Day 57 | 
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration |  | Within 4 days postdose at Day 85 | 
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration |  | Within 4 days postdose at Day 113 | 
| Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration |  | Within 4 days postdose at Day 141 | 
| Concentrations of REGN10933 in serum over time |  | Up to 52 weeks | 
| Concentrations of REGN10987 in serum over time |  | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with treatment-emergent adverse events (TEAEs) |  | Up to 52 weeks | 
| Severity of TEAEs |  | Up to 52 weeks | 
| Proportion of participants who achieve or exceed target concentration in serum of REGN10933 |  | Up to 52 weeks | 
| Proportion of participants who achieve or exceed target concentration in serum of REGN10987 |  | Up to 52 weeks | 
| Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 |  | Up to 52 weeks | 
| Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 |  | Up to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)