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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000854-27 | EudraCT Number |
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The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) in healthy participants.
This study is seeking participants who:
Participants will be divided randomly into 8 different groups. All participants will receive either one PF-07275315 or a harmless treatment that has no medical effect (placebo) intravenous (IV) infusion (given directly into a vein). Participants will take part in this study for up to 541 days. During this time, eligible participants will receive single increasing amounts of PF-07275315 or placebo. Increase will only occur if the sponsor agrees that the next dose is likely to have acceptable safety and tolerability. The follow-up visit will take place 271 days after first treatment.
This is an first-in-human within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study of the safety, tolerability, PK, and PD following single and multiple escalating doses of PF-07275315 that will be conducted in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | PF-07275315 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07275315 | Drug | Active drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Incidence and severity of AEs | Baseline through study completion, approximately 561 days |
| Number of participants with clinically meaningful change from baseline in laboratory Tests Results | Number of Participants With Change From Baseline in Laboratory Tests Results | Baseline through study completion, approximately 561 days |
| Number of participants with clinically meaningful change from baseline in vital signs | Number of participants with change from baseline in vital signs | Baseline through study completion, approximately 561 days |
| Number of participants with Serious AEs (SAEs) | Incidence and severity of SAEs | Baseline through study completion, approximately 561 days |
| Number of participants with clinically meaningful change from baseline in ECG parameters | number of participants with change from baseline in ECG parameters | Baseline through study completion, approximately 561 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Cmax will be observed directly from data. | 1- 561 Days |
| Time to Maximum Plasma Concentration (Tmax) of PF-07275315 | Tmax will be observed directly from data. |
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This study is seeking participants who:
This study is not seeking participants who have:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Lake Forest | California | 92630 | United States | ||
| Orange County Research Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| Placebo |
| Drug |
Placebo |
|
|
| 1 - 561 Days |
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07275315 | Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) | 1 - 561 Days |
| Incidence of the development of Antidrug antibodies (ADA) against PF-07275315 | To evaluate the immunogenicity profile of PF-07275315 in healthy adults. | 1 - 561 Days |
| Half-life of PF-07275315 | terminal elimination half-life will be measured | 1-561 days |
| Area under the curve (AUC) of PF-07275315 serum concentration time-profile from time zero extrapolated to infinite time | AUCinf | 1-561 days |
| AUC of PF-07275315 serum concentration time-profile over the dosing interval of 2 weeks or 336 hours | AUC336 | 1-561 days |
| Incidence of the development of neutralizing antibodies (NAb) against PF-07275315 | To evaluate the immunogenicity profile of PF-07275315 in healthy adults. | 1-561 days |
| Tustin |
| California |
| 92780 |
| United States |
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States |
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |