ABOUT THIS STUDY
- Male and/or female subjects between the ages of 18 and 65 years, inclusive, with active psoriasis lesion(s).
- Subjects should be healthy with the exception of psoriasis, where healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination. Blood pressure must be < 140/89. Body Mass Index (BMI) between 18-36 kg/m2, inclusive; and a total body weight >50 kg (110 lbs)
- The following laboratory variables must be no more than 10% below the lower limit of the normal reference range: RBC, hemoglobin, hematocrit, WBC, absolute neutrophil count. The absolute lymphocyte count must be greater than or equal to the lower limit of the reference range. Values for AST, ALT, bilirubin and alkaline phosphatase must be no more than 10% above the upper limit of the normal reference range. Values for total cholesterol and LDL must be no more than 20% above the upper limit of the normal reference range except for subjects being treated for hyperlipidemia. Normal glomerular filtration rate (> 80 mL/min).
- Subjects with evidence or history of clinically significant hematological, renal,
urological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,
psychiatric, neurologic disorder.
- Subjects with controlled essential hypertension and/or hyperlipidemia may be eligible
for the study provided that any medications that are administered.
- Screening 12-lead ECG demonstrating at least one of the following: heart rate > 100
bpm, QRS >120 msec, QTc > 430 msec (males), QTc > 450 msec (females) or PR > 220 msec.
- Abnormal chest radiographs including, but not limited to, evidence of past or present
tuberculosis infection. History of tuberculosis without treatment and/or positive
tuberculin reaction without known vaccination with BCG.
- Subjects with a history of tumors with the exception of adequately treated basal cell
carcinoma of the skin.
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