NCT05505448

A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Regeneron Anti-SARS-CoV-2 Monoclonal Antibody (a COVID-19 Therapeutic) in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (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 REGN14284 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 REGN14284 in serum * To assess the immunogenicity of REGN14284

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	REGN14284	Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
DRUG	Matching Placebo	Single ascending IV or SC administration per the protocol

Timeline

• Start date: 2022-09-15
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2022-08-17
• Last updated: 2023-07-27

Locations

1 site across 1 country: Belgium