drugset / Trial / NCT04135560

A Study To Determine The Safety, Tolerability, Skin Irritation Potential, And PK Following Topical Application Of PF-07038124 In Healthy Participants

NCT04135560

Phase 1 Completed 34 enrolled Pfizer
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

EvaluationDrugModalityDoseRoute
Subject IDREBORMILAST Small molecule 0.01 % Topical
Subject IDREBORMILAST Small molecule 0.03 % Topical
Subject IDREBORMILAST Small molecule 0.06 % Topical

Indications