Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients

Inclusion criteria

• Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;
• Subject who meets one of the following criteria:

i. History of gout attack: Meeting 2015 ACR/EULAR Gout Classification Criteria and fasting serum uric acid ≥ 480 μmol/L at screening (local laboratory of study site) ii. For asymptomatic hyperuricemia, it is acceptable to meet either of the two criteria:

• Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medical record or test report), diagnosis with hyperuricemia before screening, and fasting serum uric acid at screening ≥ 540 μmol/L (local laboratory of study site);
• Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medical record or test report), diagnosis with hyperuricemia before screening, and fasting serum uric acid at screening ≥ 480 μmol/L (local laboratory of study site), with concomitant primary hypertension or primary hyperlipidemia or type 2 diabetes mellitus, which is treated with a stable dose of antihypertensive or lipid-lowering or hypoglycemic treatment for at least 3 months;
• At screening, 18.0 kg/m2 ≤ body mass index (BMI) ≤ 32.0 kg/m2;
• Hematology, Blood chemistry and Urinalysis examination were basically normal.

Exclusion criteria

• Prior intolerance to benzbromarone or contraindication to medication;
• Secondary hyperuricemia caused by tumor, chronic kidney disease, blood disease or drugs, etc.;
• Arthropathy caused by arthritis rheumatoid, purulent arthritis, traumatic arthritis, psoriatic arthritis, pseudogout or systemic lupus erythematosus, etc.;
• Arthropathy caused by chemotherapy, radiotherapy or chronic lead poisoning;
• Urinary calculi confirmed by B-ultrasound during screening period;