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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01258088 | Safety Study of Ointment for the Treatment of Plaque-type Psoriasis | PHASE1 | COMPLETED | 16 | — | — | Nov 30, 2010 | Dec 7, 2010 | Mar 5, 2019 | 1 | Australia |
12-lead ECG, clinical laboratory tests, urinalysis, spontaneous/elicited adverse event (AE) reporting, local site reactions, physical exam and vital signs (blood pressure, heart rate).
| Arm | Type | Description |
|---|---|---|
| Cohort 1: AN2728 Ointment | ACTIVE_COMPARATOR | - |
| Cohort 1: AN2728 Vehicle | PLACEBO_COMPARATOR | - |
| Cohort 3: AN2728 Ointment | ACTIVE_COMPARATOR | - |
| Cohort 3: AN2728 Vehicle | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AN2728 Ointment | DRUG | 5mg/cm2, BID |
| AN2728 Vehicle | DRUG | 5mg/cm2 BID |
Inclusion Criteria: * White males, 18 - 55 years (inclusive) of age at the time of randomization. * Body weight between 60-90 kg (Body Mass Index \[BMI\] between 19 and 30 kg/m2 \[inclusive\]). * Willing and able to comply with study instructions and commit to all follow-up visits. * Have adequate ...