A First-in-human Study to Investigate Single Doses of DCY636 in Healthy Volunteers and Multiple D… (NCT07604324) | Clinical Trial Compass
RecruitingPhase 1
A First-in-human Study to Investigate Single Doses of DCY636 in Healthy Volunteers and Multiple Doses in Participants With Moderate to Severe Atopic Dermatitis
Japan63 participantsStarted 2026-06-02
Plain-language summary
The purpose of this first-in-human (FIH) study is to assess the safety and tolerability, pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) of DCY636. The results are intended to support the further clinical development of DCY636 in future studies.
Who can participate
Age range
18 Years – 100 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.
Key Inclusion Criteria:
Healthy Participants (Part 1)
• Healthy male and non-childbearing potential female participants 18 to 55 years of age inclusive.
Participants with moderate to severe atopic dermatitis (Part 2)
* Males and non-pregnant females age 18 years or older
* Diagnosis of atopic dermatitis for at least 1 year not adequately controlled by topicals
* Moderate to severe atopic dermatitis as defined by all of the following:
* EASI score ≥12 at screening visit and ≥16 at baseline (BL) visit
* IGA score ≥3 at screening visit and baseline visit
* Total Body surface area (BSA) affected by AD ≥ 10 % at screening visit and baseline visit
* Peak Pruritus NRS score ≥4 at baseline visit, based on weekly average of daily assessment in the week prior to baseline visit
Key Exclusion Criteria:
All Participants (Part 1, Part 2)
* Use of other investigational drugs within the last 30 days or 5 half-lives of the other drugs prior to initial dosing, whichever is longer.
* Meet any of the prohibited medication use criteria at baseline visit.
* A positive syphilis test result during screening period.
* Evidence of active or latent TB infection, as determined by T-Spot test during screening period.
* History of immunodeficiency diseases, or a positive human immunodeficiency virus (HIV) test result.
* Recent (within last half year) or ongoing helminth infection.
* History of hepatitis B or hepatitis C or serologic evidence for viral hepatitis. A positive Hepatitis B viru…
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
Part 1-Incidence of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to approximately 202 days
2
Part 2-Incidence of adverse events (AEs) and serious adverse events (SAEs)