Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07604324 | 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 | PHASE1 | RECRUITING | 63 | — | — | Jun 2, 2026 | Jan 28, 2028 | May 29, 2026 | 1 | Japan |
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.
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.
| Arm | Type | Description |
|---|---|---|
| Part 1- Cohort A1: Dose Level 1 DCY636 | EXPERIMENTAL | Cohort A1: Dose Level 1 DCY636 in healthy participants. |
| Part 1- Cohort A2: Dose Level 2 DCY636 | EXPERIMENTAL | Cohort A2: Dose Level 2 DCY636 in healthy participants. |
| Part 1- Cohort A3: Dose Level 3 DCY636 | EXPERIMENTAL | Cohort A3: Dose Level 3 DCY636 in healthy participants. |
| Part 1- Cohort A4: Dose Level 4 DCY636 | EXPERIMENTAL | Cohort A4: Dose Level 4 DCY636 in healthy participants. |
| Part 1- Cohort B1: Dose Level 5 DCY636 | EXPERIMENTAL | Cohort B1: Dose Level 5 DCY636 in healthy participants. |
| Part 1- Cohort B2: Dose Level 6 DCY636 | EXPERIMENTAL | Cohort B2: Dose Level 6 DCY636 in healthy participants. |
| 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. |
| Part 1- Cohort A1: Placebo | PLACEBO_COMPARATOR | Cohort A1: Placebo in healthy participants. |
| Part 1- Cohort A2: Placebo | PLACEBO_COMPARATOR | Cohort A2: Placebo in healthy participants. |
| Part 1- Cohort A3: Placebo | PLACEBO_COMPARATOR | Cohort A3: Placebo in healthy participants. |
| Part 1- Cohort A4: Placebo | PLACEBO_COMPARATOR | Cohort A4: Placebo in healthy participants. |
| Part 1- Cohort B1: Placebo | PLACEBO_COMPARATOR | Cohort B1: Placebo in healthy participants. |
| Part 1- Cohort B2: Placebo | PLACEBO_COMPARATOR | Cohort B2: Placebo in healthy participants. |
| Part 2- Cohort C1: Placebo | PLACEBO_COMPARATOR | Part 2- Cohort C1: Placebo in participants with moderate to severe atopic dermatitis. |
| Name | Type | Description |
|---|---|---|
| DCY636 | DRUG | Participants will receive DCY636 |
| Placebo | DRUG | Participants will receive Placebo |
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 de...