Clinical trial NCT06671834: A Study to Learn About the Study Medicine Called PF-07905428 in Healthy Participants and Participants With Acne Vulgaris
Official title: A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Dose Topical Administration of PF-07905428 in Healthy Participants and Participants With Acne Vulgaris, and Additionally Clinical Effect in Participants With Moderate to Severe Acne Vulgaris Aged 18 to 40 Years Old
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07905428) for the potential treatment of acne vulgaris.

This study is seeking participants who:

* Are male or female between the ages of 18 and 40
* Are generally healthy
* Are diagnosed with moderate to severe acne vulgaris (Cohort 4 only)

The study medicine will be applied every day on the participant's face and/or back for 14 days (Cohorts 1 and 2) or for 28 days (Cohort 3 and 4).

The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help the investigators determine if the study medicine is safe and effective.

Participants will take part in this study for approximately 2 months. During this time, they will have 17 study visits (Cohorts 1 and 2) or 31 study visits (Cohorts 3 and 4) at the study clinic. The study team will also call participants once at the end of the study over the phone.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation.
* Only for participants who are enrolling with acne vulgaris: diagnosis of acne vulgaris for 3 months or greater
* For participants enrolling in Cohort 1-3 with acne vulgaris (optional): mild to moderate facial acne vulgaris
* For participants enrolling in Cohort 4 with acne vulgaris: moderate to severe facial acne vulgaris

Exclusion Criteria:

* Participants with very severe acne
* Participants with autoinflammatory syndromes
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C.
* Participants with clinically significant laboratory abnormalities

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Through study completion, approximately 2 months
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Through study completion, approximately 2 months
measure: Number of Participants With Abnormalities in Vital Signs
timeFrame: Through study completion, approximately 2 months
measure: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters
timeFrame: Through study completion, approximately 2 months
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) of PF-07905428
timeFrame: Day 14 (Cohorts 1, 2, and 4) Day 28 (Cohorts 3 and 4)
measure: Time to maximum plasma concentration (Tmax) of PF-07905428
timeFrame: Day 14 (Cohorts 1, 2, and 4) Day 28 (Cohorts 3 and 4)
measure: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of PF-07905428
timeFrame: Day 14 (Cohorts 1, 2, and 4) Day 28 (Cohorts 3 and 4)
measure: Terminal serum elimination half life (t1/2) of PF-07905428
timeFrame: Day 14 (Cohorts 1, 2, and 4) Day 28 (Cohorts 3 and 4)
measure: Absolute change in total acne lesion counts
timeFrame: Baseline to Week 4
measure: Absolute change from baseline in inflammatory lesion counts (ILC)
timeFrame: Baseline to Week 4
measure: Absolute change in non-inflammatory lesion counts (nILC)
timeFrame: Baseline to Week 4
measure: Percentage of Participants who achieve Investigator global assessment (IGA) of 0 or 1
timeFrame: Baseline to Week 4
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: