First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants Wit… (NCT07527923) | Clinical Trial Compass
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Belgium144 participantsStarted 2026-05-22
Plain-language summary
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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of Treatment Emergent Adverse Events (TEAEs)
. 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
. History of alcohol or drug abuse as determined by the investigator
. Known or suspected history of immunosuppression
. Presence of skin comorbidities at screening that may interfere with study assessments
. Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list