NCT07527923

First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis

A Two-Part Phase 1, Randomized, Double-Blind, Placebo-Controlled First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN20423 in Adult Healthy Participants and Adult Participants With Atopic Dermatitis

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This clinical trial will evaluate REGN20423, an investigational medicine that has not previously been studied in humans and is used only in clinical studies. The study will assess the safety, how the body processes the medicine, and the dose levels that may work best. It will also test whether REGN20423 can help treat adults with atopic dermatitis. This is a two-part study: Part A includes healthy adult participants. Part B includes adults with atopic dermatitis. The Study is Looking at: * What side effects REGN20423 might cause * How much REGN20423 is in the blood at different times * How well REGN20423 works in adults with atopic dermatitis * Whether the body makes antibodies against REGN20423 * How the body changes after having REGN20423, which can help researchers understand why REGN20423 works better in some people than others * What the best dose of REGN20423 is

Conditions

• Healthy Volunteer
• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	REGN20423	Administered per the protocol
OTHER	Placebo	Administered per the protocol

Timeline

• Start date: 2026-05-04
• Primary completion: 2028-06-09
• Completion: 2028-06-09
• First posted: 2026-04-14
• Last updated: 2026-04-14

Regulatory

• FDA-regulated drug study