[Translation] A randomized, double-blind, active drug/placebo-controlled Phase Ia clinical study to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of single/multiple doses of LXH-2301 in healthy adult subjects and gout patients in remission who have not received urine alkalinization and uric acid-lowering drug treatment
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 I study:
Main purpose: To evaluate the safety and tolerability of LXH-2301 in single/multiple oral administration in healthy adult subjects;
Secondary purpose: To evaluate the PK and PD characteristics of LXH-2301 and positive control drugs in single/multiple oral administration in healthy adult subjects.
Part II study:
Main purpose: To evaluate the PK and PD characteristics of LXH-2301 and positive control drugs in single/multiple oral administration in gout patients who have not undergone alkalinization of urine and uric acid-lowering drug treatment and are in remission, as well as its effectiveness in alkalinizing urine, so as to provide a basis for the selection of clinical dosage and administration method for this product;
Secondary purpose: To evaluate the safety and tolerability of LXH-2301 in single/multiple oral administration in gout patients who have not undergone alkalinization of urine and uric acid-lowering drug treatment and are in remission;
Exploratory purpose: To evaluate the effectiveness of LXH-2301 in lowering uric acid levels when used alone.