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Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | formulation without active drug |
|
| tanezumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | single dose of the drug formulation |
| |
| tanezumab |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the change in intraepidermal nerve fiber (IENF) density in skin biopsies from proximal thigh and distal leg between baseline and postdose time points after a single SC injection of tanezumab 20 mg SC or placebo in healthy volunteers. | 16 weeks | |
| To compare the treatment effect between tanezumab 20 mg SC and placebo on the change in IENF density between baseline and postdose time points in skin biopsies from the proximal thigh and distal leg in healthy volunteers. | 16 weeks | |
| To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers | 16 weeks |
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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 Investigational Site | Overland Park | Kansas | 66211 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C549319 | tanezumab |
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| Biological |
single dose of the active drug tanezumab at a dose level of 20 mg |
|
| Overland Park |
| Kansas |
| 66212 |
| United States |