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

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia

Treatments: Drug: benzbromarone; Drug: Placebo; Drug: SHR4640

Study type: Interventional

Funder types: Industry

Identifiers

NCT03185793

SHR4640-201

Details and patient eligibility

About

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

Enrollment: 198 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo for 5 weeks

Treatment:

Drug: Placebo

2.5mg SHR4640

Experimental group

Description:

SHR4640 for 5 weeks

Treatment:

Drug: SHR4640

5mg SHR4640

Experimental group

Description:

SHR4640 for 5 weeks

Treatment:

Drug: SHR4640

10mg SHR4640

Experimental group

Description:

SHR4640 for 5 weeks

Treatment:

Drug: SHR4640

50mg benzbromarone

Active Comparator group

Description:

Benzbromarone for 5 weeks

Treatment:

Drug: benzbromarone