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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
PF-07038124 0.06% and vehicle Ointment BID applied to 1% Body Surface Area (BSA)
PF-07038124 0.01% or vehicle Ointment QD applied to 10% BSA
PF-07038124 0.01% or vehicle Ointment BID applied to 10% BSA
PF-07038124 0.03% or vehicle Ointment BID applied to 10% BSA
PF-07038124 0.06% or vehicle ointment BID applied to 10% BSA
PF-07038124 safe concentration or vehicle ointment BID applied to 20% BSA
PF-07038124 safe concentration or vehicle BID applied to 10% BSA
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States
Part A: Number of Participants with Treatment Emergent Treatment-Related Adverse Evenst (AEs)
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Time frame: through study completion, up to 38 days
Part A: Number of Adverse Events by Severity
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Time frame: through study completion, up to 38 days
Part B: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (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.
Time frame: through study completion, up to 41 days
Part B: Number of Adverse Events by Severity
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.
Time frame: through study completion, up to 41 days
Part B: Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 1 and 10
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Days 1 and 10
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time frame: Days 1 and 10
Plasma Decay Half-Life (t1/2)
Time frame: Days 1 and 10
Average Concentration at Steady State (Cav)
Time frame: Day 10
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