A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin
- Registration Number
- NCT01262690
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- Healthy subjects
Exclusion Criteria
- History of seizures, including childhood seizures.
- History of movement disorders or related neurological conditions.
- History of head trauma associated with loss of consciousness.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose PF-05230901 6 treated, 3 placebos
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Plasma concentrations 14 days Anti-drug antibodies 35 days Appetite and food consumption 13 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States