Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia

Inclusion Criteria:

• A patient with clinical diagnosis of gout (according to the 2015 ACR/EULAR goutclassification criteria), non acute attack phase, and hyperuricemia {under normalpurine diet, blood uric acid>420 µ mol/L (7 mg/dl) not tested twice on an emptystomach on the same day}。

• Screening period blood uric acid>420 µ mol/L (7mg/dl)。

Exclusion Criteria:

• Within 14 days prior to enrollment (or within 5 half lives of the drug, whichever islonger), medication that lowers uric acid levels or affects uric acid levels andrelated drugs (allopurinol, febuxostat, benzbromarone, probenecid,benzenesulfonazolone, Tongyifengning tablets, etc.) must be taken, or during thestudy period, other drugs that lower uric acid levels or affect uric acid levels andrelated drugs other than experimental drugs must not be discontinued。

• Patients with acute gout attacks within 14 days prior to enrollment。

• Previously received uric acid oxidase or treated with similar drugs such as pegolaseor rabulidase。

• Individuals with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency orG6PD enzyme activity levels below the lower limit of normal。

• Individuals with a history of catalase deficiency or evidence that meets thediagnostic criteria for catalase deficiency。

• Malignant tumor patients (whether treated or not)。