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

NCT07604324 | Not Yet Recruiting Phase 1

• 1 other identifier: CDCY636A02101
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dermatitis, Atopic

Keywords

Phase 1; FIH; safety and tolerability; healthy volunteers; PK; atopic dermatitis; AD; eczema

Outcome Measures

Primary Outcomes (2)

• Part 1-Incidence of adverse events (AEs) and serious adverse events (SAEs)

  Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.

  Up to approximately 202 days

• Part 2-Incidence of adverse events (AEs) and serious adverse events (SAEs)

  Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.

  Up to approximately 301 days

Secondary Outcomes (6)

• Part 1-Pharmacokinetic (PK) parameter: Cmax of DCY636

  up to Day 202

• Part 1-Pharmacokinetic (PK) parameter: AUC of DCY636

  up to Day 202

• Part 1-Anti-drug antibodies against DCY636

  up to Day 202

• Part 2-Pharmacokinetic (PK) parameter: Cmax of DCY636

  up to Day 301

• Part 2-Pharmacokinetic (PK) parameter: AUC of DCY636

  up to Day 301

Study Arms (14)

Part 1- Cohort A1: Dose Level 1 DCY636

EXPERIMENTAL

Cohort A1: Dose Level 1 DCY636 in healthy participants.

Drug: DCY636

Part 1- Cohort A2: Dose Level 2 DCY636

EXPERIMENTAL

Cohort A2: Dose Level 2 DCY636 in healthy participants.

Drug: DCY636

Part 1- Cohort A3: Dose Level 3 DCY636

EXPERIMENTAL

Cohort A3: Dose Level 3 DCY636 in healthy participants.

Drug: DCY636

Part 1- Cohort A4: Dose Level 4 DCY636

EXPERIMENTAL

Cohort A4: Dose Level 4 DCY636 in healthy participants.

Drug: DCY636

Part 1- Cohort B1: Dose Level 5 DCY636

EXPERIMENTAL

Cohort B1: Dose Level 5 DCY636 in healthy participants.

Drug: DCY636

Part 1- Cohort B2: Dose Level 6 DCY636

EXPERIMENTAL

Cohort B2: Dose Level 6 DCY636 in healthy participants.

Drug: DCY636

Part 2- Cohort C1: Dose Level 7 DCY636

EXPERIMENTAL

Part 2- Cohort C1: Dose Level 7 DCY636 in participants with moderate to severe atopic dermatitis.

Drug: DCY636

Part 1- Cohort A1: Placebo

PLACEBO COMPARATOR

Cohort A1: Placebo in healthy participants.

Drug: Placebo

Part 1- Cohort A2: Placebo

PLACEBO COMPARATOR

Cohort A2: Placebo in healthy participants.

Drug: Placebo

Part 1- Cohort A3: Placebo

PLACEBO COMPARATOR

Cohort A3: Placebo in healthy participants.

Drug: Placebo

Part 1- Cohort A4: Placebo

PLACEBO COMPARATOR

Cohort A4: Placebo in healthy participants.

Drug: Placebo

Part 1- Cohort B1: Placebo

PLACEBO COMPARATOR

Cohort B1: Placebo in healthy participants.

Drug: Placebo

Part 1- Cohort B2: Placebo

PLACEBO COMPARATOR

Cohort B2: Placebo in healthy participants.

Drug: Placebo

Part 2- Cohort C1: Placebo

PLACEBO COMPARATOR

Part 2- Cohort C1: Placebo in participants with moderate to severe atopic dermatitis.

Drug: Placebo

Interventions

DCY636 DRUG

Participants will receive DCY636

Part 1- Cohort A1: Dose Level 1 DCY636; Part 1- Cohort A2: Dose Level 2 DCY636; Part 1- Cohort A3: Dose Level 3 DCY636; Part 1- Cohort A4: Dose Level 4 DCY636; Part 1- Cohort B1: Dose Level 5 DCY636; Part 1- Cohort B2: Dose Level 6 DCY636; Part 2- Cohort C1: Dose Level 7 DCY636

Placebo DRUG

Participants will receive Placebo

Part 1- Cohort A1: Placebo; Part 1- Cohort A2: Placebo; Part 1- Cohort A3: Placebo; Part 1- Cohort A4: Placebo; Part 1- Cohort B1: Placebo; Part 1- Cohort B2: Placebo; Part 2- Cohort C1: Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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)
• Women of childbearing potential
• Smokers Participants with moderate to severe atopic dermatitis (Part 2)
• 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
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+81337978748; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): May 25, 2026
• Primary Completion (Estimated): January 27, 2028
• Study Completion (Estimated): January 28, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share