First test of REGN20423 in healthy adults and adults with atopic dermatitis
Tests the new medicine REGN20423 in healthy adults and adults with eczema.
Plain-language title generated from the registry record
Registry title: First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Key facts
- Where
- Birmingham, Miami, North Charleston, North Little Rock, San Antonio, Union City, West Hills, and Weston, United StatesSee the 8 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07527923, who can take part
Where in United States
- Cahaba Dermatology & Skin Health Center, LLCBirmingham, United StatesTaking people
- Florida International Research CenterMiami, United StatesTaking people
- National Allergy and Asthma Research, LLCNorth Charleston, United StatesTaking people
- Arkansas Research TrialsNorth Little Rock, United StatesTaking people
- Texas Dermatology and Laser SpecialistsSan Antonio, United StatesTaking people
- Rophe Adult and Pediatric MedicineUnion City, United StatesTaking people
- Alliance Clinical, Focus Clinical ResearchWest Hills, United StatesTaking people
- Encore Medical Research of Weston, LLCWeston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT07527923EU 2025-524205-32-00
- Record updated
- 6 November 2026
- Original description
This study will test an experimental 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.Read full original descriptionShow less
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
This study will test an experimental 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
Inclusion: Part A:; Maximum age of 65 years of age (Part A Only); 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.
Exclusion: 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; 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; Part A:; Presence of skin comorbidities at screening that may interfere with study assessments.
Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis.