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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04271514 | A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis | PHASE1 | COMPLETED | 103 | — | — | Aug 12, 2019 | Apr 26, 2021 | Sep 30, 2021 | 14 | United States, Netherlands |
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
| Arm | Type | Description |
|---|---|---|
| COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active | EXPERIMENTAL | Increasing doses of RPT193 will be administered to healthy volunteers |
| COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo | PLACEBO_COMPARATOR | Matching placebo will be administered to healthy volunteers |
| COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active | EXPERIMENTAL | Increasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers |
| COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo | PLACEBO_COMPARATOR | Matching placebo will be administered once/day for 7 days to healthy volunteers |
| COMPLETED ENROLLMENT -- Expansion Part C - active | EXPERIMENTAL | RPT193 will be administered daily for 28 days to patients with atopic dermatitis |
| COMPLETED ENROLLMENT -- Expansion Part C - placebo | PLACEBO_COMPARATOR | Matching placebo will be administered daily for 28 days to patients with atopic dermatitis |
| Name | Type | Description |
|---|---|---|
| RPT193 | DRUG | Antagonist of the CCR4 chemokine receptor |
| Placebo | DRUG | Matching placebo |
Selected Inclusion Criteria: Parts A \& B (COMPLETED ENROLLMENT): * Healthy male or female * 18-55 years of age, inclusive * At least 50 kg in weight * BMI: 18.0-30.0 kg/m2, inclusive Part C (COMPLETED ENROLLMENT): * Male or female with atopic dermatitis * 18-65 years of age, inclusive * BMI bet...