Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07264660 intravenous single ascending dose | Experimental | PF-07264660 will be administered intravenously |
|
| PF-07264660 subcutaneous multiple ascending dose | Experimental | PF-07264660 will be administered subcutaneously |
|
| Intravenous placebo | Placebo Comparator | Placebo will be administered intravenously |
|
| Subcutaneous Placebo | Placebo Comparator | Placebo will be administered subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07264660 intravenous single ascending dose | Drug | PF-07264660 will be administered intravenously in single ascending doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Research, LLC | Garden Grove | California | 92845 | United States | ||
| Collaborative Neuroscience Research, LLC |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigators and other site staff will be blinded to participants' assigned study intervention.
Participants will be assigned to receive study intervention according to the assigned treatment group from the randomization scheme. Investigators will remain blinded to each participant's assigned study intervention throughout the course of the study.
In the event of a Quality Assurance audit, the auditor(s) will be allowed access to unblinded study intervention records at the site(s) to verify that randomization/dispensing has been done accurately.
Sponsor staff not directly involved in the conduct of the study will be unblinded to participants' assigned study intervention.
| PF-07264660 subcutaneous multiple ascending dose | Drug | PF-07264660 will be administered subcutaneously in multiple ascending doses |
|
| Intravenous placebo | Other | Placebo will be administered intravenously in single ascending doses |
|
| subcutaneous placebo | Other | Placebo will be administered subcutaneously in multiple ascending doses |
|
| 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 | 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 | 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 | 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 | 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 | Baseline up to approximately 1.5 years |
Peak concentration of PF-07264660 during selected timepoints |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline up to approximately 1.5 years |
| Long Beach |
| California |
| 90806 |
| United States |
| Collaborative Neuroscience Research, LLC | Los Alamitos | California | 90720 | United States |
| Prism Research LLC dba Nucleus Network | Saint Paul | Minnesota | 55114 | United States |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | United States |
| Spaulding Clinical Research | West Bend | Wisconsin | 53095 | United States |