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| ID | Type | Description | Link |
|---|---|---|---|
| 3294K1-1000 |
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The purpose of this study is to find the safety and side effects of investigational drug in healthy volunteers. See how quickly investigational drug enters the bloodstream, is distributed in the body, broken down and removed in healthy male and female volunteers. See if your body makes antibodies to this investigational drug (how your immune system responds).
First in human study to collect safety and pharmacokinetics (PK) of single ascending dose in Healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05230905 | Other | 9 subjects will participate in each dose cohort. 6 subjects will receive investigational product (PF-05230905) and 3 subjects will receive placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05230905 | Drug | Single dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints will be evaluated by comparing reported adverse events in subjects receiving PF-05230905 versus subjects receiving placebo. | day 168 | |
| Incidence and severity of clinical laboratories including absolute hepatic transaminases and bilirubin levels will be evaluated. | day 168 | |
| Mean change from baseline in vital signs measurements. Mean change from baseline in 12 lead echocardiogram (ECG) will be compared to ensure safety of the subjects. | day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of development of Anti Drug Antibody. | day 168 | |
| Serum PF-05230905 concentrations will be determined by a validated assay, and noncompartmental pharmacokinetics (PK) parameters. | day 168 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josefin-Beate Holz, MD | Ablynx, a Sanofi company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Tacoma | Washington | 98418 | United States |
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| Urine pharmacokinetics (PK) parameters amount excreted in urine (Ae) and renal clearance will be determined. | day 168 |