Official Title
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
Brief Summary

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

Completed
Healthy
Chronic Stable Illness

Drug: REGN10933+REGN10987

Administered subcutaneous (SC) every 4 weeks (Q4W)
Other Name: Array

Drug: Placebo

Administered subcutaneous (SC) every 4 weeks (Q4W)

Eligibility Criteria

Key Inclusion Criteria:

1. 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

2. Stable medication for co-morbid condition(s) for at least 6 months prior to screening

3. 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:

1. Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization

2. Subject-reported clinical history of COVID-19 as determined by investigator

3. Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection

4. Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19

5. Medically attended acute illness, systemic antibiotics use, or hospitalization (ie,
>24 hours) for any reason within 30 days prior to screening

6. Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary
disease [COPD], asthma exacerbations) in the past 6 months prior to screening

7. Received investigational or approved SARS-CoV-2 vaccine

8. Received investigational or approved passive antibodies for SARS-CoV-2 infection
prophylaxis as defined in the protocol

9. 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 90 Years
Countries
United States
Locations

Regeneron Study Site
Tempe, Arizona, United States

Regeneron Study Site
Rogers, Arkansas, United States

Regeneron Study Site
Sacramento, California, United States

Regeneron Study Site
Miami, Florida, United States

Regeneron Study Site
Lincoln, Nebraska, United States

Regeneron Study Site
Dayton, Ohio, United States

Regeneron Study Site
Austin, Texas, United States

Clinical Trial Management, Study Director
Regeneron Pharmaceuticals

Regeneron Pharmaceuticals
NCT Number
Keywords
Coronavirus Disease 2019 (COVID-19)
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
MeSH Terms
Casirivimab and imdevimab drug combination