Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia

Inclusion criteria

• 18-70 years, male or female;
• Subject meets one of the following conditions:

• Subject with a history of gout has a serum uric acid ≥480μmol/l at screening; 2) Subject with a history of hyperuricemia has a serum uric acid ≥540μmol/l at screening, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3) Subject with a history of hyperuricemia has a serum uric acid≥480μmol/l at screening, on stable treatment for hypertensive, hyperlipidemia or diabetes for at least 3 month, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3. 18kg/m2≤ BMI ≤32kg/m2.

Exclusion criteria

• Subject who is pregnant or breastfeeding;
• Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;
• Estimated glomerular filtration rate (MDRD formula) ˂60ml/min;
• HbA1c˃8%;
• Subject with known hypersensitivity or allergy to SHR4640 or any component of SHR4640;
• Subject with a history of malignancy;
• Subject with a history of urolithiasis, or positive findings on ultrasound examination at screen
• Subject within the last 3months has: myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemia attack;
• Subject has acute gout flares within 2 weeks before randomization;
• Subject who is taking any other urate-lowering medication (allopurinol, febuxostat, probenecid and benzbromarone) that is indicated within 2 weeks before randomization and can not stop during the study;
• Subject who is taking more than 100mg once daily or unstable dosage aspirin within 2 weeks before randomization and can not stop during the study;
• Subject who is taking any diuretic within 2 weeks before randomization and can not stop during the study.