drugset / Trial / NCT05181683

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

NCT05181683

Phase 1 Completed 45 enrolled Regeneron Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2022-01-07
Primary completion
2022-06-03
Completion
2022-06-03

Drugs

EvaluationDrugModalityDoseRoute
Subject casirivimab Monoclonal antibody Intravenous
Subject imdevimab Monoclonal antibody Intravenous

Indications

No indication recorded.