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

A Phase 1, Randomized, Open-Label Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy
• Chronic Stable Illness

Interventions

Type	Name	Description
DRUG	Casirivimab+Imdevimab	Randomized 1:1 for intravenous (IV) or subcutaneous (SC) administration

Timeline

• Start date: 2022-01-07
• Primary completion: 2022-06-03
• Completion: 2022-06-03
• First posted: 2022-01-06
• Last updated: 2025-10-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study