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The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.
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The purpose of this clinical trial is to learn if the study medicine (called PF-07314470) is safe and how it gets in and out of the body in healthy people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14 | Experimental | Participants will receive a single dose of PF-07314470 at 1 of 7 dose levels |
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| Placebo for PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14 | Placebo Comparator | Participants will receive a single dose of placebo for PF-07314470 |
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| PF-07314470; Cohorts 9 to 13 | Experimental | Participants will receive PF-07314470 weekly at 1 of 4 dose levels for 4 doses, or every 2 weeks at 1 dose level for 3 doses. |
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| Placebo for PF-07314470; Cohorts 9 to 13 | Placebo Comparator | Participants will receive placebo for PF-07314470 weekly for 4 doses, or every 2 weeks for 3 doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07314470 | Biological | subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events Following Single Doses | Day 1 up to approximately Day 35 | |
| Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Single Doses | Baseline up to approximately Day 35 | |
| Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Single Doses | Baseline up to approximately Day 35 | |
| Number of Participants with Clinically Significant Change from Baseline in ECGs Following Single Doses | Baseline up to approximately Day 35 | |
| Number of Participants with Treatment Emergent Adverse Events Following Multiple Doses | Day 1 up to approximately Day 64 | |
| Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Multiple Doses | Baseline up to approximately Day 64 | |
| Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Multiple Doses | Baseline up to approximately Day 64 | |
| Number of Participants with Clinically Significant Change from Baseline in ECGs Following Multiple Doses | Baseline up to approximately Day 64 | |
| Number of Participants with Serious Adverse Events Following Single Doses |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of PF-07314470 Following Single Doses | Day 1 up to approximately Day 35 | |
| Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Single Doses |
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Key Inclusion Criteria:
Key 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 - New Haven | New Haven | Connecticut | 06511 | United States |
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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 for PF-07314470 | Biological | subcutaneous injection |
|
| Day 1 up to approximately Day 35 |
| Number of Participants with Serious Adverse Events Following Multiple Doses | Day 1 up to approximately Day 64 |
| Day 1 up to approximately Day 35 |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Single Doses | Day 1 up to approximately Day 35 |
| Area Under the Serum Concentration-time Curve from Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07314470 Following Single Doses | If data permit | Day 1 up to approximately Day 35 |
| Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Single Doses | If data permit | Day 1 up to approximately Day 35 |
| Area Under the Serum Concentration-time Curve at Steady State Over the Dosing Interval (AUCtau) of PF-07314470 Following Multiple Doses | Day 1 up to approximately Day 64 |
| Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Multiple Doses | Day 1 up to approximately Day 64 |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Multiple Doses | Day 1 up to approximately Day 64 |
| Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Multiple Doses | If data permit | Day 1 up to approximately Day 64 |
| Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Single Doses | Day 1 up to approximately Day 35 |
| Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Single Doses | If appropriate | Day up to approximately Day 35 |
| Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Multiple Doses | Day 1 up to approximately Day 64 |
| Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Multiple Doses | If appropriate | Day 1 up to approximately Day 64 |