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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04135560 | A Study To Determine The Safety, Tolerability, Skin Irritation Potential, And PK Following Topical Application Of PF-07038124 In Healthy Participants | PHASE1 | COMPLETED | 34 | — | — | Oct 29, 2019 | Apr 10, 2020 | May 14, 2020 | 1 | United States |
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Assessment of AEs, safety laboratory tests, vital signs (including blood pressure, pulse rate and temperature), cardiac telemetry and 12-lead ECGs. Incidence and severity of local skin irritation.
Assessment of AEs, safety laboratory tests, vital signs (including blood pressure, pulse rate and temperature), cardiac telemetry and 12-lead ECGs. Incidence and severity of local skin irritation.
| Arm | Type | Description |
|---|---|---|
| Part A Cohort 1 (1% Body Surface Area) | EXPERIMENTAL | Each participant in this cohort will receive both PF-07038124 0.06% and vehicle applied to the skin (1% Body Surface Area) |
| Part B Cohort 1 (10% Body Surface Area) | EXPERIMENTAL | - |
| Part B Cohort 2 (10% Body Surface Area) | EXPERIMENTAL | - |
| Part B Cohort 3 (10% Body Surface Area) | EXPERIMENTAL | - |
| Part B Cohort 4 (10% Body Surface Area) | EXPERIMENTAL | - |
| Part B Cohort 5 (20% Body Surface Area) | EXPERIMENTAL | - |
| Part B Cohort 6 (10% Body Surface Area) | EXPERIMENTAL | Optional cohort of Japanese participants |
| Name | Type | Description |
|---|---|---|
| PF-07038124 and Vehicle | DRUG | PF-07038124 0.06% and vehicle Ointment BID applied to 1% Body Surface Area (BSA) |
| PF-07038124 or vehicle | DRUG | PF-07038124 0.01% or vehicle Ointment QD applied to 10% BSA |
Inclusion Criteria: 1. Healthy female participants of non-childbearing potential and/or male participants who, at the time of screening, must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD): 2. Male and female participants who are healthy as determine...