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PF-07853578 · 1 trial · 1 indication
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (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.
Pre-defined categorical criteria for laboratory abnormalities included: Lymphocytes \<0.8 x lower limit of normal (LLN); Basophils/Leukocytes \> 1.2 x upper limit of normal (ULN); Eosinophils/Leukocytes \>1.2 x ULN; Monocytes/Leukocytes \>1.2 x ULN; low-density lipoprotein (LDL) Direct Endpoint Measure \>1.2 x ULN; Triglycerides \>1.3 x ULN; Specific Gravity \<1.003 or \>1.030; pH \>8; Ketones ≥1; Urobilinogen (EU) ≥1; URINE Bilirubin ≥1; Leukocyte Esterase ≥1.
Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg.
ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) ≥300 millisecond (msec), b) ≥25% increase when baseline is \> 200 msec, c) ≥50% increase when baseline is less than or equal to (≤) 200 msec. 2\. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline. 3\. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and ≤480 msec, b) \>480 msec and ≤500 msec, c) \>500 msec, d) \>30 msec and ≤60 msec increase from baseline, e) \>60 msec increase from baseline.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo. |
| Cohort 2 | EXPERIMENTAL | Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo. |
| Cohort 3 | EXPERIMENTAL | Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo. |
| Name | Type | Description |
|---|---|---|
| PF-07853578 | DRUG | PF-07853578 will be administered as oral solutions or suspensions as escalating single doses to be determined. |
| Placebo | DRUG | Placebo will be administered as oral solutions or suspensions as escalating single doses to be determined. |
Inclusion Criteria: 1. Female participants of non-childbearing potential and male participants aged 18 to 65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. 2. BMI of 16 to 30.5...
PF-07853578 is an investigational small molecule being developed by Pfizer, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy participants, and its therapeutic area is classified as Other. It is not approved and remains in clinical testing.
PF-07853578 is being studied for use in healthy participants. The completed Phase 1 trial aimed to learn about the study medicine and how it acts in the bodies of healthy adults. Its intended therapeutic use has not been specified beyond this initial healthy volunteer study.
PF-07853578 is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical research on this investigational small molecule drug candidate.
PF-07853578 is in Phase 1 clinical development. The single trial for this drug, NCT05890105, has been completed. The drug is investigational and has not been approved by regulatory authorities. It is still in the early stages of clinical testing.
PF-07853578 has one completed clinical trial, NCT05890105, titled "A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults." This Phase 1 study enrolled 23 healthy participants in the United States and was randomized, double-blind, and controlled.