Clinical Trial

Testing Experimental Medication in Healthy Subjects

Study Description

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

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - PF-07038124 and Vehicle

PF-07038124 0.06% and vehicle Ointment BID applied to 1% Body Surface Area (BSA)

Drug - PF-07038124 or vehicle

PF-07038124 0.01% or vehicle Ointment QD applied to 10% BSA

Drug - PF-07038124 or vehicle

PF-07038124 0.01% or vehicle Ointment BID applied to 10% BSA

Drug - PF-07038124 or vehicle

PF-07038124 0.03% or vehicle Ointment BID applied to 10% BSA

Drug - PF-07038124 or vehicle

PF-07038124 0.06% or vehicle ointment BID applied to 10% BSA

Drug - PF-07038124 or vehicle

PF-07038124 safe concentration or vehicle ointment BID applied to 20% BSA

Drug - PF-07038124 or vehicle

PF-07038124 safe concentration or vehicle BID applied to 10% BSA

Additional Information

Official Study Title

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, FIRST-IN-HUMAN, LOCAL TOLERABILITY AND DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE-DOSE, TOPICAL ADMINISTRATION OF PF-07038124 TO HEALTHY PARTICIPANTS

Clinical Trial ID

NCT04135560

ParticipAid ID

azpG8d