NCT07527923RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 7 Apr 2026
- Start date
- 22 May 2026
- Primary completion date
- 23 Jun 2028
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07527923
- EU CT number
- 2025-524205-32-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 144
- From 22 May 2026 to the primary completion date, 23 Jun 2028
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hospitalized (\>24 hours) for any reason within 30 days prior to the screening visit
- 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
- Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list
Other illness
- Hypersensitivity to the study treatment or any of its excipients
- History of clinical parasite infection, except treated trichomoniasis
- History of alcohol or drug abuse as determined by the investigator
- Part B:
- Known or suspected history of immunosuppression
- Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study
- Note: Other protocol defined Inclusion/ Exclusion criteria apply
Other
- Part A:
- Presence of skin comorbidities at screening that may interfere with study assessments
Who the study is looking for
- Part A:
- 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
- Has a BMI within 18 to 31 kg/m² (inclusive) at the screening visit
- Part B:
- Has a history of AD for at least 6 months at screening
- Has EASI score ≥5 at both the screening and baseline visits
- Has IGA score ≥2 at both the screening and baseline visits
Criteria the registry did not label
- Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven) Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Cahaba Dermatology & Skin Health Center, LLC Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Florida International Research Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| National Allergy and Asthma Research, LLC Coordinator of this site? Confirm its status | North Charleston | United States | Recruiting |
| Arkansas Research Trials Coordinator of this site? Confirm its status | North Little Rock | United States | Recruiting |
| Texas Dermatology and Laser Specialists Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Alliance Clinical West Hills (Focus Clinical Research) Coordinator of this site? Confirm its status | West Hills | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.