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| ID | Type | Description | Link |
|---|---|---|---|
| TAM-163 FIH Study; 3279K1-1000 |
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The study was terminated on 21-Sept-2011 due to the emergent safety concern of sensory symptoms.
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This study will examine whether a single dose of PF-05230901 is safe and well tolerated when given to healthy volunteers by injection under the skin. An additional objective is to measure the blood concentrations of PF-05230901. Each dose will be tested in a different group of subjects starting from the lowest dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose | Experimental | 6 treated, 3 placebos |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05230901 | Drug | Single ascending doses of PF-05230901 in separate cohorts of subjects; each cohort consists of 6 subjects treated with PF-05230901 and 3 subjects treated with placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events. | 35 days | |
| Incidence and severity of clinical laboratory abnormalities. | 35 days | |
| Mean change from baseline in vital signs. | 35 days | |
| Mean change from baseline in 12-lead electrocardiogram (ECG) parameters. | 35 days | |
| Incidence and severity of findings during the neurological examination. | 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations | 14 days | |
| Anti-drug antibodies | 35 days | |
| Appetite and food consumption |
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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 | 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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| ID | Term |
|---|---|
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| PF-05230901 | Drug | Single dose SC |
|
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| 13 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |