NCT05923424

A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN17092, an Anti-SARS-CoV-2 (COVID-19) Monoclonal Antibody, in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to learn about the safety and tolerability of different doses of REGN17092 administered with a needle either under the skin (called "subcutaneous") or into a vein (called an "infusion") in healthy participants. This is the first time that REGN17092 will be given to people. Other aims are to assess: * How much of the study drug is in the blood at different times * Whether the body makes its own antibodies against the study drug (which could make the drug less effective or lead to side effects)

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	REGN17092	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: 2023-11-28
• Primary completion: 2025-03-04
• Completion: 2025-03-04
• First posted: 2023-06-28
• Last updated: 2025-03-27

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study