A Study to Evaluate the Pharmacokinetics and Safety of ASP015K in Healthy Chinese Subjects
A Study to Evaluate the Pharmacokinetics and Safety of ASP015K in Healthy Chinese Subjects
The purpose of this study is to evaluate the pharmacokinetics and safety of ASP015K after
 single-dose and multiple-dose administration in healthy Chinese participants.
Inclusion Criteria:

 -  Normal Body Mass index (BMI) and weight: BMI[= weight kg/(height m)^2] > 19 kg/m^2 and
 ≤ 24 kg/m^2, the weight is no less than 50 kg for male and 45 kg for female at
 screening.

 -  Female subject must either: Be of non-childbearing potential, postmenopausal (defined
 as at least 1 year without any menses) prior to screening, or documented surgically
 sterile. Or, if of childbearing potential: agree not to try to become pregnant during
 the study and for 60 days after the final study drug administration, must have a
 negative pregnancy at Screening and Day -1, and if heterosexually active, agree to
 consistently use 1 form of highly effective birth control starting at Screening and
 throughout the study period, and for 60 days after the final study drug
 administration.

 -  Female subject must agree not to breastfeed starting at Screening and throughout the
 study period, and for 60 days after the final study drug administration.

 -  Female subject must not donate ova starting at Screening and throughout the study
 period, and for 60 days after the final study drug administration.

 -  Male subject and female spouse/partners who are of childbearing potential must be
 using 1 form of highly effective birth control starting at Screening and throughout
 the study period, and for 90 days after the final study drug administration.

 -  Male subject must not donate sperm starting at Screening and throughout the study
 period, and for 90 days after the final study drug administration.

 -  Subject agrees not to participate in another interventional study while participating
 in the present study, defined as signing the informed consent form until completion of
 the last study visit.

 Exclusion Criteria:

 -  Female subject who has been pregnant within 6 months prior to screening or breast
 feeding within 3 months prior to screening.

 -  Subject has a known or suspected hypersensitivity to ASP015K, or any components of the
 formulation used.

 -  Subject has any of the liver chemistry tests (aspartate aminotransferase [AST],
 alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma-glutamyl transferase
 [GGT] and total bilirubin [TBL]) above the upper limit of normal on Day -1. In such a
 case, the assessment may be repeated once.

 -  Subjects who meet any of the following criterion for laboratory tests on Day -1.
 Normal ranges of each test specified at the study site or test/assay organization will
 be used as the normal ranges in this study. In such a case, the assessment may be
 repeated once.

 -  Hematology: a deviation of +20% from the upper limit or -20% from the lower limit
 of the normal range, and clinically significant.

 -  Blood biochemistry: a deviation from the normal range regarding serum creatinine,
 serum electrolytes (Na, K, and Cl), or fasting blood glucose; a deviation of +20%
 from the upper limit or -20% from the lower limit of the normal range regarding
 laboratory test items other than above, and clinically significant. However, the
 lower limit of the normal range will not be established for lactate dehydrogenase
 (LD), creatinine kinase (CK), total cholesterol, triglyceride, urea, serum
 creatinine, and uric acid, whose deviation from the lower limit is considered not
 clinically significant.

 -  Urinalysis: a deviation from the normal range of each urinalysis test item.

 -  Subject has any clinically significant history of allergic conditions (including drug
 allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated,
 asymptomatic, seasonal allergies at time of dosing).

 -  Subject has any history or evidence of any clinically significant cardiovascular,
 gastrointestinal endocrinologic, hematologic, hepatic, immunologic, metabolic,
 urologic, respiratory,pulmonary, neurologic, cerebrovascular, lymphatic, dermatologic,
 psychiatric, renal, and/or other major disease or malignancy.

 -  Subject has/had febrile illness or symptomatic, viral, bacterial (including upper
 respiratory infection), or fungal (noncutaneous) infection within 1 week prior to Day
 -1.

 -  Subject has any clinically significant abnormality in the physical examination,
 12-lead electrocardiogram (ECG) and protocol defined clinical laboratory tests at
 Screening or Day -1.

 -  Subject has a pulse rate < 45 or > 100 bpm; systolic blood pressure (SBP) > 140 mmHg;
 diastolic blood pressure (DBP) > 90 mmHg (measurements taken after subject has been
 resting in sit position for 5 min; pulse will be measured automatically) at screening
 or on Day -1. If the pulse rate or blood pressure exceeds the limits above, 1
 additional test can be taken.

 -  Subjects with abnormal body temperature, defined as axillary temperature >37.3 ºC or
 <35.0 ºC at Screening or Day -1.

 -  Subject has a corrected QT interval (QTcF) of > 430 ms (for males) and > 450 ms (for
 females) at screen or on Day -1(at screen and on Day-1, will be performed). If the
 QTcF exceeds the limits above on Day-1, 1 additional ECG test can be taken.

 -  Subject has any history or evidence of congenital short QT syndrome(defined as QTc <
 330 ms).

 -  Subject has any history of gastrointestinal resection (excepted appendectomy)..

 -  Subject has developed upper gastrointestinal symptoms within 1 week prior to Day -1.

 -  Subject applies to any of the following concerns with regard to tuberculosis.

 -  History of active tuberculosis

 -  Abnormalities detected in a chest X-ray test at Screening

 -  Contact with infectious tuberculous patients

 -  T-spot or Quantiferon Gold test show tuberculosisinfection positive.

 -  Subject applies to any of the following concerns with regard to infection other than
 tuberculosis.

 -  Complication or history of severe herpes zoster or herpes zoster disseminated.

 -  At least twice of relapse of localized herpes zoster

 -  Inpatient hospital care for severe infectious diseases within 90 days prior to
 Day -1

 -  Treatment with intravenous antibiotics within 90 days prior to Day -1
 (prophylactic antibiotics are not applicable).

 -  Other than above, with a high risk of developing infectious disease (subjects
 with urethral catheterisation etc.).

 -  Subject has vaccination of live vaccines or live attenuated vaccines within 56 days
 prior to Day -1 (inactivated vaccines such as influenza vaccine and pneumococcal
 vaccines are not applicable.).

 -  Subject has used any prescribed or nonprescribed drugs (including vitamins or natural
 and herbal remedies, e.g. St. John's Wort) in the 2 weeks prior to study drug
 administration.

 -  Subject has a history of smoking more than 10 cigarettes (or equivalent amount of
 tobacco) per day within 3 months prior to admission to the clinical unit.

 -  Subject has a history of drinking more than 21 units of alcohol per week (1 unit = 10
 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine
 [12%]) (> 14units of alcohol for female subjects) within 3 months prior to admission
 to the clinical unit or the subject tests positive for alcohol or drugs of abuse at
 Screening or Day -1 (amphetamines,barbiturates, benzodiazepines, cannabinoids,
 cocaine, and opiates).

 -  Subject has used any drugs of abuse within 3 months prior to admission to the clinical
 unit.

 -  Subject has had significant blood loss, donated 1 unit (450 mL) of blood or more, or
 received a transfusion of any blood or blood products within 60 days or donated plasma
 within 7 days prior to Day -1.

 -  Subject has a positive serology test for hepatitis B surface antigen (HBsAg),
 antihepatitis A virus (immunodeficiency virus [Ig]M), anti-hepatitis C virus,
 anti-hepatitis B core or antihuman immunodeficiency virus (HIV) at Screening.

 -  Subject has participated in any clinical study or has been treated with any
 investigational drugs within 3 moths prior to screening.

 -  Subject has any condition which makes the subject unsuitable for study participation.

 -  Subject is an employee of the Astellas Group, Clinical Research Organization (CRO) or
 the clinical unit.