[Translation] Evaluation of the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of FCN-342 tablets in healthy volunteers and patients with asymptomatic hyperuricemia: a single-center, randomized, double-blind, placebo-controlled, single-dose and multiple-dose escalation phase I clinical study
主要目的:研究健康志愿者及无症状高尿酸血症患者单次服用FCN-342片以及无症状高尿酸血症患者多次服用FCN-342片后的安全性和耐受性。次要目的:观察单次服用FCN-342片后,健康志愿者及无症状高尿酸血症患者的FCN-342药代动力学和药效学特征;观察多次服用FCN-342片后,无症状高尿酸血症患者的FCN-342的药代动力学和药效学特征;探索性目的:初步评估食物对无症状高尿酸血症患者口服FCN-342片人体药动学特征的影响;评估健康志愿者口服FCN-342片后的代谢与排泄特征。测定尿液和粪便中FCN-342及主要代谢产物(如必要);探索性分析鉴定中国健康受试者口服 FCN-342片后血浆、尿液和粪便中代谢产物(如必要)。探索以上代谢产物药代动力学特征(如必要);评估健康志愿者/无症状高尿酸血症患者口服FCN-342片后的C-QTc、群体PK/PD、暴露-效应(ER)关系。
[Translation] Primary objective: To investigate the safety and tolerability of FCN-342 tablets after a single dose in healthy volunteers and patients with asymptomatic hyperuricemia and after multiple doses in patients with asymptomatic hyperuricemia. Secondary objective: To observe the pharmacokinetic and pharmacodynamic characteristics of FCN-342 in healthy volunteers and patients with asymptomatic hyperuricemia after a single dose of FCN-342 tablets; To observe the pharmacokinetic and pharmacodynamic characteristics of FCN-342 in patients with asymptomatic hyperuricemia after multiple doses of FCN-342 tablets; Exploratory objective: To preliminarily evaluate the effect of food on the human pharmacokinetic characteristics of FCN-342 tablets in patients with asymptomatic hyperuricemia; To evaluate the metabolism and excretion characteristics of FCN-342 tablets after oral administration in healthy volunteers. To determine FCN-342 and its main metabolites in urine and feces (if necessary); To conduct exploratory analysis to identify metabolites in plasma, urine and feces of healthy Chinese subjects after oral administration of FCN-342 tablets (if necessary). Explore the pharmacokinetic characteristics of the above metabolites (if necessary); evaluate the C-QTc, population PK/PD, and exposure-effect (ER) relationship in healthy volunteers/patients with asymptomatic hyperuricemia after oral administration of FCN-342 tablets.