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

• Status: Completed
• Trial end date: 2018-07-20
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Benzbromarone

Criteria

Inclusion Criteria:

1. 18-70 years, male or female;

2. Subject meets one of the following conditions:

1) 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:

1. Subject who is pregnant or breastfeeding;

2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;

3. Estimated glomerular filtration rate (MDRD formula) ˂60ml/min;

4. HbA1c˃8%;

5. Subject with known hypersensitivity or allergy to SHR4640 or any component of SHR4640;

6. Subject with a history of malignancy;

7. Subject with a history of urolithiasis, or positive findings on ultrasound examination at screen

8. 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;

9. Subject has acute gout flares within 2 weeks before randomization;

10. 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;

11. 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;

12. Subject who is taking any diuretic within 2 weeks before randomization and can not stop during the study.