Approval Probability
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PF-07905428 · 1 trial · 1 indication
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included SAEs and all non-SAEs that occurred during the study.
Evaluation of participants with clinically meaningful changes from baseline in laboratory test results
Any untoward vital sign findings that are identified during the active collection period and meet the definition of an AE or SAE.
12-lead ECG were performed after the participant had rested quietly for at least 10 minutes in a supine position. ECG parameters included RR interval, PR interval, QRS complex, QT interval, corrected QT (QTc) interval, Bazett's correction QT (QTcB) interval, Heart Rate and Fridericia's correction (QTcF) interval. Clinical significance of 12-Lead ECG was judged by investigator.
| Arm | Type | Description |
|---|---|---|
| PF-07905428 Low Strength | EXPERIMENTAL | Participants may receive 0.08% PF-07905428 QD. Area of application will be increased as the study proceeds from one cohort to the next. |
| PF-07905428 High Strength | EXPERIMENTAL | Participants may receive 0.24% PF-07905428 QD. Area of application will be increased as the study proceeds from one cohort to the next. |
| Placebo | PLACEBO_COMPARATOR | All participants will receive Placebo QD. Area of application will be increased as the study proceeds from one cohort to the next. |
| Name | Type | Description |
|---|---|---|
| PF-07905428 | DRUG | Topical solution of PF-07905428 0.08% or PF-07905428 0.24% |
| Placebo | DRUG | Topical solution of placebo |
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...
PF-07905428 is an investigational small molecule being developed for the treatment of acne vulgaris. It is currently in Phase 1 clinical development and is being studied in healthy participants and participants with acne vulgaris.
PF-07905428 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for acne vulgaris.
PF-07905428 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed to evaluate the drug in healthy participants and those with acne vulgaris.
PF-07905428 has one completed Phase 1 clinical trial, identified as NCT06671834. This study enrolled 52 participants and was conducted in Canada. The trial was randomized, double-blind, and placebo-controlled, including healthy volunteers and participants with acne vulgaris.
PF-07905428 is the primary name for this investigational drug. No alternative names have been disclosed in the available clinical trial information. It is a unique small molecule being studied for acne vulgaris.