The the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of XNW3009 in Health Subject

Who cannot join

• 1. Subjects who have a clinically relevant intolerance or allergy to drugs, or are known or suspected to have hypersensitivity to any ingredient in the investigational products or other URAT1 inhibitors; 2. Have a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs. Note: a subject who has had an appendectomy or hernia repair can be enrolled in the study; 3. Subjects with a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders; 4. Current or chronic history of liver disease or known hepatic or biliary abnormalities, including but not limited to ALT, alkaline phosphatase and bilirubin >ULN.
• 5. Current or history of cardiac arrhythmias (symptomatic or asymptomatic); 6. Recent or current serious infection (within 30 days of screening). Examples include cellulitis, pneumonia, septicemia. Subjects with mild upper respiratory tract infection may be enrolled at the discretion of the investigator; 7. Estimating glomerular filtration rate (using the Modification of Diet in Renal Disease method based on serum creatinine and actual age) < 90 ml/min/1.73m2; 8. Major illness or surgery (except for minor outpatient surgery) within past 3 months of study Day 1, or planned surgery during study; 9. Subjects with intolerance to direct venipuncture; 10. Subjects with a history of, or signs and symptoms associated with, renal calculi or gout; 11. Known or suspected history of drug abuse within the past 2 years or presence of drug abuse within 3 months before screening, or evidence of such abuse on laboratory assays at screening and Day -2 unless explained by a therapeutic dose of a prescribed medication that was ceased at least 14 days prior to Day 1. Up to 1 repeat permitted; 12. Habitual use of tobacco or nicotine products or smoking within 3 months (more than 5 cigarettes per day) prior to screening, and, unwilling to refrain from use of tobacco and nicotine containing products from 24 hours before Day -2 until completion of the confinement period; 13. Unwilling to refrain from caffeinated beverages (i.e. tea, coffee, etc) from 24 hours before Day -2 until completion of the confinement period; 14. Participation in any clinical study with an investigational drug, biologic or device within 4 weeks or 5 times the half-life of the specific drug/biologics (whichever is longer), prior to dosing; 15. Donated blood >400 mL or significant blood loss equivalent to 400 mL or received blood transfusion within 3 months of screening, or donated blood >200 mL or significant blood loss equivalent to 200 mL within 1 month prior to screening; or plans to donate blood during the study; 16. Malignancy within 5 years of screening visit (excluding non-melanoma skin cancer that has been resected); 17. Recent administration or plans to receive administration of live vaccine within 12 weeks before Day 1 up to 30 days after the last dose of IP; 18. Use of any other drug, including prescription and over-the-counter medications, within 7 days prior to the first dose of study medication should be discussed with the Investigator. Where appropriate, such medication should be ceased prior to dosing. The subject may be enrolled if the medication taken or residual drug present is not expected to interfere either with subject safety or study results.
• Paracetamol at a dose of <2 g in 24 hours but no more than 1 g in 4 hours;
• Dietary vitamins may be allowed at the discretion of the investigator (e.g. Vitamin D taken at a standard replacement dose, and at a time remote from IP administration);
• Herbal supplements are not permitted; 19. Use of food or beverages likely to influence liver metabolism 14 days prior to the first dose of the study drug (e.g. star fruit, pomelos, grapefruit \& seville oranges); 20. History of significant alcohol abuse within 6 months of screening or any indication of regular use of more than 14 units of alcohol per week (1 Unit=360 mL of beer or 45 mL of alcohol 40% or 150 mL of wine) and, unwilling to refrain from consumption of alcohol from 24 hours before Day -2 until completion of the confinement period; 21. Positive screening test for any one or more: serum hepatitis B surface antigen (HBsAg), hepatitis C antibody, or HIV; 22. Pregnant or lactating women; 23. Subject who is considered unsuitable for participating in the study in the opinion of investigator.