NCT05293678

Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the safety and tolerability of REGN15160 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs). The secondary objectives of the study are: * To assess the concentration-time profile of REGN15160 in serum * To assess the immunogenicity of REGN15160

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	REGN15160 (IV)	Administered in single intravenous (IV) dose
DRUG	Matching Placebo (IV)	Administered in single IV dose
DRUG	REGN15160 (SC)	Administered in single subcutaneous (SC) dose
DRUG	Matching Placebo (SC)	Administered in single SC dose

Timeline

• Start date: 2022-04-12
• Primary completion: 2023-01-26
• Completion: 2023-01-26
• First posted: 2022-03-24
• Last updated: 2023-02-23

Locations

1 site across 1 country: Belgium