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| ID | Type | Description | Link |
|---|---|---|---|
| FIP | Other Identifier | Alias Study Number | |
| Japanese Ph1 | Other Identifier | Alias Study Number |
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06946860 in healthy adult Japanese participants following single dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06946860 | Experimental | Single subcutaneous administration of PF-06946860 |
|
| Placebo | Placebo Comparator | Single subcutaneous administration of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06946860 | Biological | PF-06946860 administered subcutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of participants experiencing AE | Up to 20 weeks post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed PF-06946860 Concentration (Cmax) | Up to 20 weeks post-dose | |
| Area Under the Curve From Time Zero to Last Quantifiable PF-06946860 Concentration (AUClast) | Up to 20 weeks post-dose |
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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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials LLC-Clinical Research | Anaheim | California | 92801 | 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 |
| Other |
Placebo administered subcutaneously |
|
| Time to Reach Maximum Observed PF-06946860 Concentration (Tmax) | Up to 20 weeks post-dose |
| PF-06946860 Half-Life (t1/2) | Time measured for the PF-06946860 concentration to decrease by one half. | Up to 20 weeks post-dose, as data permit |
| Incidence of development of ADA, and if necessary NAb, against PF-06946860 | Up to 20 weeks post-dose, as data permit |