A Phase 1 interventional study of PF-07264660 intravenous single ascending dose and PF-07264660 subcutaneous multiple ascending dose in Healthy, sponsored by Pfizer. Completed at 6 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
The purpose of this clinical trial is to learn about the safety and effects of study medicine PF-07264660 compared to a placebo. This is the first study of PF-07264660 in humans. All participants in this study will received PF-07264660 or a placebo and it will be assigned by chance. People may be able to participate if they are healthy. The study medicine may be given by shots under the skin or through a vein depending on which group you are assigned to. If you are assigned into Part A, you will receive the study medicine once, stay overnight at the research unit from 3 to 5 overnight stays and you will need to visit the clinic about 11 follow-up visits. Participants will be in this study for up to about 541 days. If you are assigned into Part B, you will receive the study medicine three times, stay overnight at the clinic from 3 to 5 overnight stays and you will need to visit the research unit about 12 follow-up visits. Participants willbe in this study for up to about 561 days.
This is an first-in-human within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study of the safety, tolerability, pharmacokinetics, and pharmacodynamics following single ascending dose and multiple ascending dose.
PF-07264660 that will be conducted in healthy adults. Up to approximately 67 participants will be enrolled into the study and randomly assigned to receive PF-07264660 or placebo. This will include up to approximately 43 healthy participants (including 5 optional Japanese participants) in Part A, and up to approximately 24 healthy participants (including 8 participants in optional multiple ascending dose cohort) in Part B.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PF-07264660 will be administered intravenously
Drug: PF-07264660 intravenous single ascending dose
PF-07264660 will be administered subcutaneously
Drug: PF-07264660 subcutaneous multiple ascending dose
Placebo will be administered intravenously
Other: Intravenous placebo
Placebo will be administered subcutaneously
Other: subcutaneous placebo
PF-07264660 will be administered intravenously in single ascending doses
PF-07264660 will be administered subcutaneously in multiple ascending doses
Placebo will be administered intravenously in single ascending doses
Placebo will be administered subcutaneously in multiple ascending doses
Number of participants with treatment emergent treatment related adverse events (AE's)
To evaluate the safety and tolerability of PF 07264660, following single and multiple doses in healthy adults
Time frame: Baseline up to approximately 1.5 years
Number of participants with treatment emergent treatment-related serious adverse events (SAE's)
To evaluate the safety and tolerability of PF 07264660, following single and multiple doses in healthy adults
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in blood pressure
Identify systolic and diastolic readings that are outside the normal range. The number and percentage of participants who experienced significant blood pressure change from baseline will be summarized
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in pulse rate
Identify pulse rate readings that are outside the normal range. The number and percentage of participants who experienced significant pulse rate change from baseline will be summarized
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in temperature
Identify temperature readings that are outside the normal range. The number and percentage of participants who experienced significant temperature change from baseline will be summarized
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in clinical laboratory values
Identify laboratory abnormalities from baseline will be summarized
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in heart rate
Determine the effect of the drug on heart rate The number and percentage of participants who experienced heart rate changes will be summarized
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in QT interval
Determine the effect of the drug on QT interval. The number and percentage of participants who experienced QT interval changes will be summarized
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in corrected QT interval
Determine the effect of the drug on corrected QT interval. The number and percentage of participants who experienced corrected QT interval changes will be summarized
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in PR interval
Determine the effect of the drug on PR interval. The number and percentage of participants who experienced PR interval changes will be summarized
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in QRS interval
Determine the effect of the drug on QRS interval. The number and percentage of participants who experienced QRS interval changes will be summarized
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in area under the concentration versus time curve from time zero to the last quantifiable time point (AUClast) of single ascending doses of PF-07264660
AUC of PF 07264660 will be calculated at selected timepoints
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in maximum plasma concentration (Cmax) of PF-07264660 after a single dose
Peak concentration of PF-07264660 during selected timepoints
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in maximum plasma concentration (Cmax) of PF-07264660 after multiple doses
Peak concentration of PF-07264660 during selected timepoints
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in time to maximum plasma concentration (Tmax) of PF-07264660 after a single dose
Time to peak concentration of PF-07264660 during selected timepoints
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in time to maximum plasma concentration (Tmax) of PF-07264660 after multiple doses
Time to peak concentration of PF-07264660 during selected timepoints
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in terminal elimination half-life (t½) of PF-07264660 after a single dose
Terminal elimination half-life of PF-07264660 during selected timepoints
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in terminal elimination half-life (t½) of PF-07264660 after multiple doses
Terminal elimination half-life of PF-07264660 during selected timepoints
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in area under the serum concentration time profile from time 0 extrapolated to infinite time (AUCinf) of single ascending doses of PF-07264660
AUC of PF 07264660 will be calculated at selected timepoints
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in area under the concentration time profile from time zero to time tau (τ), the dosing interval (AUCtau) of multiple ascending doses of PF-07264660
AUC of PF 07264660 will be calculated at selected timepoints
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in incidence and titers of anti-drug antibodies against PF-07264660
Number of participants with the presence of anti-PF-07264660 antibodies
Time frame: Baseline up to approximately 1.5 years
Number of participants with change from baseline in incidence and titers of neutralizing antibodies against PF-07264660
Number of participants with the presence of anti-PF-07264660 antibodies
Time frame: Baseline up to approximately 1.5 years
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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