Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-07295324 · 1 trial · 1 indication
An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment. A SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. Treatment-related AEs and SAEs were determined by the investigator.
Hematology parameters included hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils, reticulocytes, and lymphocytes. Chemistry parameters included blood urea nitrogen, creatinine, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Only those categories in which at least 1 participant had abnormal data were reported.
Criteria for abnormality in vital signs: supine pulse rate \<40 beats per minute (bpm) or \>120 bpm; supine diastolic blood pressure (DBP) \<50 mmHg, maximum increase or decrease from baseline of \>=20 mmHg; supine systolic blood pressure (SBP) \<90 mmHg, maximum increase or decrease from baseline of \>=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here.
ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450\<= QTcF \<480, 480\<= QTcF \<500, and QTcF \>=500; QTcF maximum increase from baseline (msec): 30\<= change \<60, and change \>=60; 2) maximum PR interval (msec): \>=300; PR increase from baseline (msec): baseline \>200 with 25% increase at maximum, baseline \<=200 with 50% increase at maximum; 3) maximum QRS (msec): \>=140; QRS increase from baseline (msec) \>=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here.
Application site toleration was assessed by Draize scoring. Draize scores were defined as: 0 = No reaction visible, 1 = Trace reaction - barely perceptible pinkness, 2 = Mild reaction - readily visible pinkness, 3 = Moderate reaction - definite redness, 4 = Strong to severe reaction - very intense redness. Participants with at least 1 instance of Draize score \>0 were listed.
| Arm | Type | Description |
|---|---|---|
| PF-07295324 | EXPERIMENTAL | Ointment |
| PF-07259955 | EXPERIMENTAL | Cream |
| Name | Type | Description |
|---|---|---|
| PF-07295324 | DRUG | Ointment |
| PF-07259955 | DRUG | Cream |
Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: Age and Sex: 1. Healthy (except obese) female participants of non-childbearing potential and/or male participants, at the time of screening, must be 18 to 60 years of age, inclusi...
PF-07295324 is an investigational small molecule being developed by Pfizer, Inc. It is currently in Phase 1 clinical development. The drug is being studied for use in healthy volunteers, and it is administered topically. As of now, it remains investigational and has not been approved by regulatory authorities.
PF-07295324 is being studied for use in healthy volunteers as part of a first-in-human clinical trial. The trial aims to evaluate the effects of multiple doses of the topically administered drug. Its specific therapeutic indication has not been established, as it is still in early-stage clinical development.
PF-07295324 is being developed by Pfizer, Inc., a biopharmaceutical company. Pfizer is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule. The company is responsible for the drug's development and regulatory strategy.
PF-07295324 is in Phase 1 clinical development. This phase typically involves initial studies in small groups of participants to assess safety, tolerability, and pharmacokinetics. The drug is investigational and has not been approved for any use. It is being studied in healthy volunteers.
PF-07295324 is being studied in clinical trial NCT05206604, titled "A First-in-human Study of Multiple Doses of Topically Administered PF-07295324 and PF-07259955." This Phase 1 trial has been completed and enrolled 24 healthy volunteers in the United States. The study was randomized, double-blind, and controlled.
PF-07295324 and PF-07259955 are distinct investigational drugs being studied together in the same clinical trial. The trial NCT05206604 evaluates multiple doses of both topically administered compounds. They are separate small molecules developed by Pfizer, Inc., and are not alternative names for the same drug.