The EDC is live today — see what ships now
All studies
NCT07527923From ClinicalTrials.govRecruiting

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

  • Healthy Volunteer
  • Atopic Dermatitis

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Regeneron Pharmaceuticals
Enrolment target
144
Started
22 May 2026
Main results due
23 June 2028
Study sites
5
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 65 years.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis

Key Inclusion Criteria:

Part A:

1. Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at screening and prior to initial dose of study intervention
2. Has a BMI within 18 to 31 kg/m² (inclusive) at the screening visit

   Part B:
3. Has a history of AD for at least 6 months at screening
4. Has EASI score ≥5 at both the screening and baseline visits
5. Has IGA score ≥2 at both the screening and baseline visits

Key Exclusion Criteria

Part A:

1. Hospitalized (\>24 hours) for any reason within 30 days prior to the screening visit
2. Hypersensitivity to the study treatment or any of its excipients
3. History of clinical parasite infection, except treated trichomoniasis
4. Received a live attenuated vaccine within 1 month prior to the first screening visit or anticipates need for a live attenuated vaccine during the study
5. History of alcohol or drug abuse as determined by the investigator

   Part B:
6. Known or suspected history of immunosuppression
7. Presence of skin comorbidities at screening that may interfere with study assessments
8. Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list
9. Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study

Note: Other protocol defined Inclusion/ Exclusion criteria apply

What this study is about

In the sponsor’s own words, from the registry.

This study will test a study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B). REGN20423 is a study medicine that is only used in clinical studies. REGN20423 has not previously been studied in humans.

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

Study sites(5)

  • Cahaba Dermatology & Skin Health Center, LLC

    Birmingham, Alabama, United States

    Recruiting

  • Alliance Clinical West Hills (Focus Clinical Research)

    West Hills, California, United States

    Recruiting

  • National Allergy and Asthma Research, LLC

    North Charleston, South Carolina, United States

    Recruiting

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, United States

    Recruiting

  • Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven)

    Leuven, Vlaams-Brabant, Belgium

    Recruiting

Showing 5 of 5 sites. 5 of the 5 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07527923. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Derm | Trialion