Puliginurad

The main purpose of this study is to explore the safety and efficacy of YL-90148 tablets 4mg, 6mg, and 8mg in patients with gout, with serum uric acid less than or equal to 360umol/l as the primary efficacy endpoint and adverse events as the safety endpoint. The total administration was observed for 12 weeks. The safety endpoints were mainly the discomfort symptoms and laboratory tests (blood routine, urine routine, electrocardiogram, vital signs, blood biochemistry (total bilirubin, conjugated bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, glutamyl transferase, total protein, albumin, urea/urea nitrogen, creatinine, uric acid, triglycerides, total cholesterol, blood lipase, blood amylase, potassium, sodium, chloride, calcium, phosphorus, fasting blood glucose, creatine kinase, lactate dehydrogenase) during the administration period. The drug was administered once a day, and a total of 45 cases were enrolled, with 15 cases in each dose group. Patients in different dose groups came to the hospital for visits at different time points. For example, patients in the 4 mg dose group came to the hospital for visits on the 14th, 28th, 56th, and 84th days after enrollment, and were followed up on the 91st day. If any adverse events occurred, follow-up would be continued. At the same time, the relationship between dose and toxicity was evaluated through population pharmacokinetics and renal function indicators.

To evaluate the efficacy and safety of YL-90148 tablets in patients with gout and/or asymptomatic hyperuricemia. To verify the uric acid-lowering effect and safety events of YL-90148 tablets compared with placebo and allopurinol in patients with gout and/or asymptomatic hyperuricemia. The main purpose is to observe the ratio of serum uric acid less than 360umol/l in each group after 6 weeks of administration and to observe the safety of each group through safety indicators such as blood and urine routine tests and blood biochemistry.