Hyperuricemia
Conditions
Keywords
SHR4640, Phase II, monotherapy, dose-finding
Brief summary
The objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia.
Interventions
DRUGPlacebo
Placebo once daily for 5 weeks
DRUGSHR4640
1mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks
DRUGbenzbromarone
25mg benzbromarone once daily for a week, 50mg benzbromarone once daily for 4 weeks
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a serum uric level≤360μmol/l. | Week 5 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in serum uric level . | Week 5 |
| Rate of gout flares requiring treatment. | Up to week 5 |
| Incidence of gout flares requiring treatment. | Up to week 5 |
| Actual change from baseline in serum uric level. | Week 5 |
| Proportion of subjects with a serum uric level consistent ≤360μmol/l | At week 3, 4 and 5 |
| Actual change from baseline in serum uric level | At week 1, 2, 3 and 4 |
| Percentage change from baseline in serum uric level | At week 1, 2, 3 and 4 |
| Proportion of subjects with a serum uric level≤360μmol/l | At week1, 2, 3 and 4 |
Countries
China
Outcome results
None listed