[Translation] To evaluate the safety, tolerability and pharmacokinetics/drugs of single/multiple doses of LXH-2301 in healthy adult subjects and gout patients in remission without alkalinizing urine or urate-lowering drugs. Randomized, double-blind, active drug/placebo controlled phase Ia clinical study on efficacy (PK/PD)
第一部分研究:
主要目的:评价健康成年受试者单/多次口服LXH-2301的安全性和耐受性;
次要目的:评价健康成年受试者单/多次口服LXH-2301与阳性对照药物的PK及PD特征。
第二部分研究:
主要目的:评价未行碱化尿液及降尿酸药物治疗且处于缓解期的痛风患者单/多次口服LXH-2301与阳性对照药物的PK及PD特征,以及其碱化尿液的有效性,为本品上市的临床给药剂量和给药方式选择提供依据;
次要目的:评价未行碱化尿液及降尿酸药物治疗且处于缓解期的痛风患者单/多次口服LXH-2301的安全性和耐受性;
探索性目的:评估单独使用LXH-2301时降尿酸水平的有效性。
[Translation] Part One Research:
Main purpose: To evaluate the safety and tolerability of single/multiple oral doses of LXH-2301 in healthy adult subjects;
Secondary purpose: To evaluate the PK and PD characteristics of single/multiple oral administration of LXH-2301 and positive control drugs in healthy adult subjects.
Part Two Research:
Main purpose: To evaluate the PK and PD characteristics of single/multiple oral administration of LXH-2301 and positive control drugs in gout patients who have not been treated with alkalinizing urine and uric acid-lowering drugs and are in remission, as well as its effectiveness in alkalinizing urine. Provide a basis for the selection of clinical dosage and administration method for this product on the market;
Secondary purpose: To evaluate the safety and tolerability of single/multiple oral doses of LXH-2301 in gout patients who are in remission and have not received alkalinizing urine or urate-lowering drug treatment;
Exploratory purpose: To evaluate the effectiveness of LXH-2301 alone in lowering uric acid levels.