Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023

Inclusion criteria

• Subjects are required to meet the following criteria in order to be included in the study:

• Japanese subjects must have both natural (not adopted) parents and four grandparents of Japanese origin.
• Caucasian subjects must be of European or Latin American descent (i.e., White).
• Male or female (of non-childbearing potential only) between minimum adult legal age (according to local laws for signing the informed consent document) and 55 years of age.
• Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose:

• hysteroscopic sterilization;
• bilateral tubal ligation or bilateral salpingectomy;
• hysterectomy;
• bilateral oophorectomy, or;
• be postmenopausal with amenorrhea for at least 1 year prior to the first dose and have FSH serum levels consistent with postmenopausal status as per Investigator judgment.
• Male subjects must use reliable forms of contraception during sexual intercourse with female partners from screening to 30 days after the end of dosing.
• Good general health as determined by medical history, and by results of physical examination, chest x-ray, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administration.

Exclusion criteria

• Subjects with the following characteristics will be excluded from the study:

• History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
• Blood pressure and heart rate are outside the ranges 90-140 mmHg systolic, 60-90mmHg diastolic, heart rate 60-100 beats/min.
• 12-lead ECG with any abnormality judged by the Investigator to be clinically significant, QRS >= 120 milliseconds (msec), or QTcF interval of > 450 msec for men or > 470msec for women.
• Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug.
• Any screening laboratory evaluation outside the laboratory reference range that is judged by the Investigator to be clinically significant.
• History of or current active tuberculosis (TB) infection; history of latent TB that has not been fully treated or current latent TB infection as indicated by a positive QuantiFERON-TB test.
• History of significant allergy to any medication as judged by the Investigator.
• History of alcohol or drug abuse within the past 24 months.