NCT07526116

A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adults

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN22044 in Healthy Adult Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This clinical study will evaluate the study drug, REGN22044, in healthy participants. REGN22044 has not previously been studied in humans. The purpose of this study is to learn: * What side effects may happen when REGN22044 is taken * How much of REGN22044 is in the blood at different times * Whether the body makes antibodies against REGN22044 (which could make the drug less effective or could lead to side effects)

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	REGN22044	Administered per the protocol
DRUG	Placebo	Administered per the protocol

Timeline

• Start date: 2026-05-07
• Primary completion: 2027-05-27
• Completion: 2027-05-27
• First posted: 2026-04-13
• Last updated: 2026-04-13

Regulatory

• FDA-regulated drug study