NCT07527923 First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
| NCT ID | NCT07527923 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Regeneron Pharmaceuticals |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-05-22 |
| Primary Completion | 2028-08-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 160 participants in total. It began in 2026-05-22 with a primary completion date of 2028-08-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis Key Inclusion Criteria: Part A: 1. Maximum age of 65 years of age (Part A Only) 2. 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 3. Has a BMI within 18 to 31 kg/m² (inclusive) at the screening visit Part B: 4. Has a history of AD for at least 6 months at screening 5. Has EASI score ≥5 at both the screening and baseline visits 6. 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
Contact & Investigator
Clinical Trial Management
STUDY DIRECTOR
Regeneron Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07527923 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07527923 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07527923 currently recruiting?
Yes, NCT07527923 is actively recruiting participants. Contact the research team at clinicaltrials@regeneron.com for enrollment information.
Where is the NCT07527923 trial being conducted?
This trial is being conducted at Birmingham, United States, North Little Rock, United States, West Hills, United States, Miami, United States and 5 additional locations.
Who is sponsoring the NCT07527923 clinical trial?
NCT07527923 is sponsored by Regeneron Pharmaceuticals. The principal investigator is Clinical Trial Management at Regeneron Pharmaceuticals. The trial plans to enroll 160 participants.