- Healthy male and/or female subjects of non childbearing potential between the ages of
18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities
identified by a detailed medical history, full physical examination, including blood
pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- Female subjects of non childbearing potential must meet at least one of the following
criteria:
1. Achieved postmenopausal status, defined as: cessation of regular menses for at
least 12 consecutive months with no alternative pathological or physiological
cause; and have a serum follicle stimulating hormone (FSH) level within the
laboratory's reference range for postmenopausal females;
2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
3. Have medically confirmed ovarian failure. All other female subjects (including
females with tubal ligations and females that do NOT have a documented
hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered
to be of childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legal representative) has been informed of all pertinent aspects of
the study.
- X-ray with no evidence of current, active TB or previous inactive TB, general
infections, heart failure, malignancy, or other clinically significant abnormalities
taken at Screening or within 3 months prior to Day 1 and read by a qualified
radiologist.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- Subjects with a history of or current positive results for any of the following
serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody
(HBcAb), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV).
- Subjects with a history of autoimmune disorders.
- Subjects with a history of allergic or anaphylactic reaction to a therapeutic drug.
- History of tuberculosis or active, latent or inadequately treated tuberculosis
infection.
- Treatment with an investigational drug within 30 days (or as determined by the local
requirement, whichever is longer) or 5 half lives or 180 days for biologics preceding
the first dose of study medication.
- Pregnant females; breastfeeding females; and females of childbearing potential.