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| ID | Type | Description | Link |
|---|---|---|---|
| FIH | 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 subjects following single ascending doses This is the first clinical study of PF-06946860.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 0.1 mg, or placebo |
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| Cohort 2 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 0.3 mg, or placebo |
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| Cohort 3 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 1 mg, or placebo |
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| Cohort 4 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 3 mg, or placebo |
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| Cohort 5 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 10 mg, or placebo |
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| Cohort 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06946860 | Biological | PF-06946860 administered subcutaneously |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of participants experiencing AE. | Up 9 weeks post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Baseline, up to 9 weeks post dose, as data permit | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Baseline, up to 9 weeks post dose, as data permit |
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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 New Haven Clinical Research Unit | 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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| Experimental |
Single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo |
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| Cohort 7 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 100 mg, or placebo |
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| Optional: Cohort 8 | Experimental | Optional: single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo in healthy Japanese subjects |
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| Placebo | Other | Placebo, administered subcutaneously |
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| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Baseline, up to 9 weeks post dose, as data permit |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Baseline, up to 9 weeks post dose, as data permit |
| Incidence of development of ADA, and if necessary NAb, against PF-06946860 | Baseline, up to 9 weeks post-dose, as data permit |