NCT05481333

A Trial to Learn if REGN7999 is Safe and Well Tolerated, and How it Works in the Body of Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7999, a TMPRSS6 Antagonist, in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (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 single ascending intravenous (IV) and subcutaneous (SC) doses of REGN7999 in healthy adult participants. The secondary objectives of the study are: * To characterize the drug concentration profile of single doses of IV or SC REGN7999 * To assess the immunogenicity of single ascending SC or IV doses of REGN7999

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	REGN7999	Ascending IV or SC dose administered per protocol
DRUG	Placebo	Ascending IV or SC dose administered per protocol

Timeline

• Start date: 2022-10-24
• Primary completion: 2023-08-29
• Completion: 2023-08-29
• First posted: 2022-08-01
• Last updated: 2024-07-24

Locations

1 site across 1 country: Belgium