Trials / Completed
CompletedNCT04135560
A Study To Determine The Safety, Tolerability, Skin Irritation Potential, And PK Following Topical Application Of PF-07038124 In Healthy Participants
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-10-29
- Primary completion
- 2020-04-10
- Completion
- 2020-04-10
- First posted
- 2019-10-22
- Last updated
- 2020-05-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04135560. Inclusion in this directory is not an endorsement.