PF-07832837 for Healthy Adults and Atopic Dermatitis
This study is testing a new drug called PF-07832837. It's a first-in-human (FIH) study, meaning it's one of the first times this drug is being given to people. The main goals are to see how safe PF-07832837 is, how well people tolerate it, and how the body processes it. The study includes healthy adults and adults with moderate to severe atopic dermatitis (a skin condition causing itchy, inflamed skin). Researchers will give different doses of PF-07832837 or a placebo (an inactive substance) to participants. The study will look for side effects and serious side effects, changes in lab tests, and heart activity (ECG) to determine if the drug is safe. The study is currently unclear on its recruitment status and aims to enroll 119 participants.
- Study design
- This is a randomized, placebo-controlled study with two parts. Part 1 involves healthy adults, and Part 2 involves adults with moderate to severe atopic dermatitis, with approximately 28 participants in Part 2.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety, lab abnormalities, and ECG changes from baseline up to Day 35 after receiving single doses.
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FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients
At a glance
Conditions
Where it's being run
5 sites across 4 statesStudy leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and serious adverse events (SAEs) Following single ascending doses (SAD)Baseline up to Day 35
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.
- Number of Participants with Clinically significant Laboratory Abnormalities Following SADBaseline up to Day 35
Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.
- Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following SADBaseline up to Day 35
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, corrected QT (QTc) intervals and QRS complex. Clinically significant findings were determined by the investigator.
- Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following SADBaseline up to Day 35
Vital signs included blood pressure, pulse rate, respiratory rate, oxygen saturation and oral temperature. Clinically significant findings were determined by the investigator.
- Number of Participants with Clinically Significant Change from Baseline in Cardiac Telemetry Findings Following SADDay 1
Cardiac telemetry was collected in Part 1 SAD cohorts only. Number of participants with any cardiac telemetry abnormalities were reported in this outcome measure.
- Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs Following multiple ascending doses (MAD)Baseline up to Day 50
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.
- Number of Participants with Clinically significant Laboratory Abnormalities Following MADBaseline up to Day 50
Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.
- Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following MADBaseline up to Day 50
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, corrected QT (QTc) intervals and QRS complex. Clinically significant findings were determined by the investigator.
- Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs in participants with atopic dermatitis (AD)Baseline up to Day 80
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.
- Number of Participants with Clinically significant Laboratory Abnormalities in participants with ADBaseline up to Day 80
Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.
- Number of Participants with Clinically Significant Change from Baseline in Vital Signs in participants with ADBaseline up to Day 78
Vital signs included blood pressure, pulse rate, respiratory rate, oxygen saturation and oral temperature. Clinically significant findings were determined by the investigator.