COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers

Key Inclusion Criteria:

• Is healthy, or has chronic medical condition(s) that per the opinion of the investigator is (are) stable, well-controlled, and not likely to require medical intervention through the end of study
• Does not require medication(s) for co-morbid condition, or has received stable medication(s) for co-morbid condition(s) for at least 6 months prior to screening
• Weighs between ≥60 kg and ≤100 kg at the time of screening
• Has SARS-CoV-2-negative reverse-transcriptase polymerase chain reaction (RT-PCR) from a sample collected ≤72 hours prior to randomization, using local assay and sample collection and assay standards
• Has completed a full course of COVID-19 vaccination more than 6 weeks prior to randomization

Key Exclusion Criteria:

• Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator
• Has recent SARS-CoV-2 infection that resolved within 6 weeks prior to randomization
• Prior use of casirivimab+imdevimab at any time prior to randomization
• Prior, current, or planned use during the study of any of the following treatments: COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 (eg, bamlanivimab and etesevimab, sotrovimab), intravenous immunoglobulin (any indication), or any other investigational, authorized, or approved agent intended for COVID-19 treatment or prevention (with the exception of COVID-19 vaccines)
• Treatment with another investigational drug in the last 30 days or within 5 half-lives of the investigational drug, whichever is longer, prior to screening
• Body mass index (BMI) ≥28 kg/m2
• Medically-attended acute illness, systemic antibiotics use, or hospitalization 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
• Uncontrolled hypertension, in the opinion of the investigator
• History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure (coronary, carotid, or peripheral vascular), or intracardiac device placement (eg, pacemaker) within 12 months prior to screening
• Cancer requiring treatment currently or in the past 5 years, except for non-melanoma skin cancer or cervical/anus in-situ
• Is pregnant at screening

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply