drugset / Trial / NCT04135560
A Study To Determine The Safety, Tolerability, Skin Irritation Potential, And PK Following Topical Application Of PF-07038124 In Healthy Participants
RandomizedSequentialQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the skin irritation potential of PF-07038124 ointment and vehicle (placebo) in Part A following multiple-doses applied topically to healthy participants. In Part B, the safety, tolerability, pharmacokinetic (PK), and skin irritation potential of PF-07038124 will be evaluated. In Part A, the highest concentration of 0.06% PF-07038124 will be applied to normal skin with a small surface area of 20 cm2 (0.1% body surface area \[BSA\]), while Part B will evaluate application of PF-07038124 and vehicle (placebo) to a surface area of 2000 cm2 (10% BSA) and 4000 cm2 (20% BSA). These data will provide support for clinical development in participants with mild to moderate AD.
Timeline
- Start
- 2019-10-29
- Primary completion
- 2020-04-10
- Completion
- 2020-04-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IDREBORMILAST | Small molecule | 0.01 % | Topical |
| Subject | IDREBORMILAST | Small molecule | 0.03 % | Topical |
| Subject | IDREBORMILAST | Small molecule | 0.06 % | Topical |