The primary objective of the study is to assess the safety and tolerability of co-formulated subcutaneous (SC) and intravenous (IV) casirivimab+imdevimab The secondary objectives of the study are to: * Explore variability in the drug concentration profiles of casirivimab and imdevimab after co-formulated subcutaneous (SC) or intravenous (IV) administration * Characterize the immunogenicity of casirivimab and imdevimab in serum over time
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Randomized 1:1 for intravenous (IV) or subcutaneous (SC) administration
Regeneron Study Site
Miami, Florida, United States
Regeneron StudySite
Winter Park, Florida, United States
Targeted grade ≥3 treatment-emergent adverse events (TEAEs)
Time frame: Through end of study, approximately 16 weeks
Grade ≥3 injection-site reactions (ISRs)
Time frame: Through end of study, approximately 16 weeks
Grade ≥2 infusion-related reactions (IRRs)
Time frame: Through end of study, approximately 16 weeks
Grade ≥2 hypersensitivity reactions
Time frame: Through end of study, approximately 16 weeks
Serious adverse events (SAEs)
Time frame: Through end of study, approximately 16 weeks
Concentrations of casirivimab and imdevimab in serum over time
Time frame: Up to 16 weeks
Incidence and titer of anti-drug antibodies (ADA) to casirivimab and imdevimab
Time frame: Up to 16 weeks
Incidence of neutralizing antibodies (NAb) to casirivimab and imdevimab
Time frame: Up to 16 weeks
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