First test of DCY636 in healthy volunteers and people with atopic dermatitis
Tests the safety of DCY636 in healthy adults and adults with atopic dermatitis.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Fukuoka, JapanSee the site
- 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 55 years old?
Source: NCT07604324, who can take part
Where in Japan
- FukuokaFukuoka, JapanTaking 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
- Novartis Pharmaceuticals
- Trial code
- NCT07604324
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
A Two-part, Randomized, Participant- and Investigator-blinded, Placebo Controlled First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of DCY636 in a Single Ascending Dose Part in Healthy Participants and in a Multiple Dose Part in Participants With Moderate to Severe Atopic Dermatitis
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.
Inclusion: 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.
Exclusion: 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; Regular use (more than 2 visits per week) of a tanning booth/parlor or extended sun exposure (per investigator judgement) within 4 weeks prior to baseline visit; 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 virus surface antigen (HBsAg), Hepatitis B virus core antibody (HBcAb) and/or Hepatitis B surface antibody (HBsAb) test during screening period excludes a participant. A positive test for HBsAb can be included if the test for HBsAg and HBcAb are negative and the history of hepatitis B vaccination is known. Participants with a positive Hepatitis C virus (HCV) antibody test should be excluded; Healthy Participants (Part 1); Have any chronic, uncontrolled medical condition, which would put the participant at increased risk during study participation, such as uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, cardiovascular, pulmonary, hepatic, renal, neurologic or psychiatric disease, or other disease of concern, as per investigator judgment; Women of childbearing potential (WOCBP) are excluded unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 202 days (= 5 times the terminal half-life) of study treatment after stopping study treatment; Other protocol-defined inclusion/exclusion criteria may apply; All Participants (Part 1, Part 2); A positive syphilis test result during screening period; Women of childbearing potential; Smokers Participants with moderate to severe atopic dermatitis (Part 2).