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

NCT04135560 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-05-14

No results posted yet for this study

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.

Conditions

  • Dermatitis Atopic

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-29
Primary Completion
2020-04-10
Completion
2020-04-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04135560 on ClinicalTrials.gov