First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants Wit… (NCT07527923) | Clinical Trial Compass
Not Yet RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
136 participantsStarted 2026-05-04
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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 criteria
✕. Hospitalized (\>24 hours) for any reason within 30 days prior to the screening visit
✕. Hypersensitivity to the study treatment or any of its excipients
✕. History of clinical parasite infection, except treated trichomoniasis
✕. 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
What they're measuring
1
Occurrence of Treatment Emergent Adverse Events (TEAEs)