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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-520380-13-00 | Registry Identifier | CTIS (EU) |
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The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-07999415) in healthy adult participants.
This study is seeking volunteers aged 18 to 65 years old who do not have any major health issues.
Some participants in this study will receive a single dose of PF-07999415 as a shot in the thigh, abdomen, or arm at the study clinic. Afterward, participants will stay in a hospital-like setting for 2 weeks, where they will be monitored for reactions to the study medicine.
The study team will compare the experiences of people receiving PF-07999415 to those of the people who do not. This will help the study team decide if PF-07999415 is safe.
Participants will take part in this study for 3 to 7 months. During this time, participants will stay at the healthcare facility for 2 weeks and then come back for study visits every 2 weeks until completing the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07999415 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07999415 | Biological | Participants will receive single doses of PF-07999415. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events. | First dose (Day 1) to up to final follow-up visit (Day 85) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) for PF-07999415 | First dose (Day 1) to up to final follow-up visit (Day 85) | |
| Maximum observed concentration (Cmax) for PF-07999415 | First dose (Day 1) to up to final follow-up visit (Day 85) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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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 |
Participants will receive matching placebo. |
|
| Time to maximum observed concentration (Tmax) for PF-07999415 | First dose (Day 1) to up to final follow-up visit (Day 85) |