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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
∙ 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
Locations
Other Locations
Japan
Novartis Investigative Site
RECRUITING
Fukuoka
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+81337978748
Backup
Novartis Pharmaceuticals
Time Frame
Start Date:2026-06-02
Estimated Completion Date:2028-01-28
Participants
Target number of participants:63
Treatments
Experimental: Part 1- Cohort A1: Dose Level 1 DCY636
Cohort A1: Dose Level 1 DCY636 in healthy participants.
Experimental: Part 1- Cohort A2: Dose Level 2 DCY636
Cohort A2: Dose Level 2 DCY636 in healthy participants.
Experimental: Part 1- Cohort A3: Dose Level 3 DCY636
Cohort A3: Dose Level 3 DCY636 in healthy participants.
Experimental: Part 1- Cohort A4: Dose Level 4 DCY636
Cohort A4: Dose Level 4 DCY636 in healthy participants.
Experimental: Part 1- Cohort B1: Dose Level 5 DCY636
Cohort B1: Dose Level 5 DCY636 in healthy participants.
Experimental: Part 1- Cohort B2: Dose Level 6 DCY636
Cohort B2: Dose Level 6 DCY636 in healthy participants.
Experimental: Part 2- Cohort C1: Dose Level 7 DCY636
Part 2- Cohort C1: Dose Level 7 DCY636 in participants with moderate to severe atopic dermatitis.
Placebo_comparator: Part 1- Cohort A1: Placebo
Cohort A1: Placebo in healthy participants.
Placebo_comparator: Part 1- Cohort A2: Placebo
Cohort A2: Placebo in healthy participants.
Placebo_comparator: Part 1- Cohort A3: Placebo
Cohort A3: Placebo in healthy participants.
Placebo_comparator: Part 1- Cohort A4: Placebo
Cohort A4: Placebo in healthy participants.
Placebo_comparator: Part 1- Cohort B1: Placebo
Cohort B1: Placebo in healthy participants.
Placebo_comparator: Part 1- Cohort B2: Placebo
Cohort B2: Placebo in healthy participants.
Placebo_comparator: Part 2- Cohort C1: Placebo
Part 2- Cohort C1: Placebo in participants with moderate to severe atopic dermatitis.