1. Healthy female subjects and/or male subjects, who, at the time of screening, are
between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically
relevant abnormalities identified by a detailed medical history, complete physical
examination including blood pressure and pulse rate measurement, 12 lead
electrocardiogram (ECG), and clinical laboratory tests.
2. Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110
pounds).
3. Chest X ray with no evidence of current, active TB or previous (inactive) TB, fungal
or general infections, heart failure, malignancy, or other clinically significant
abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a
qualified radiologist.
4. Female subjects of non childbearing potential must meet at least one of the following
criteria: a. Achieved postmenopausal status, defined as follows: cessation of regular
menses for at least 12 consecutive months with no alternative pathological or
physiological cause; status may be confirmed by having a serum follicle stimulating
hormone (FSH) level confirming the post menopausal state; b. Have undergone a
documented hysterectomy and/or bilateral oophorectomy; c. Have medically confirmed
ovarian failure.
All other female subjects (including females with tubal ligations) will be considered to be
of childbearing potential.
1. Evidence or history of clinically significant infectious, hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurologic, autoimmune, or allergic disease (including drug allergies, but excluding
untreated, asymptomatic, seasonal allergies at time of dosing).
2. Evidence or history of nervous system demyelinating diseases (including multiple
sclerosis, optic neuritis, Guillain Barré syndrome).
3. History of relevant orthostatic hypotension, fainting spells or blackouts.
4. Previous history of cancer, except for adequately treated basal cell or squamous cell
carcinoma of the skin