[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetics and food effects of single/multiple oral doses of YZJ-3058 tablets in healthy adult subjects
第一阶段:单剂给药剂量递增(SAD)研究+食物影响(FE)研究:
主要目的:1 评估健康成人空腹条件下单剂口服YZJ-3058 片后的安全性和耐受性。 2 评估健康成人空腹条件下单剂口服YZJ-3058 片后YZJ-3058 及其代谢产物(如适用)的药代动力学特性。3评估食物对健康成人单剂口服YZJ-3058 片后药代动力学特性的影响。
次要目的:1评估健康成人空腹条件下单剂口服YZJ-3058 片后尿样、粪样中YZJ-3058 及其代谢产物的累积排出率。2 评估空腹条件下单剂口服YZJ-3058 片给药剂量递增在健康成人中药物浓度-QT 间期(C-QT)变化关系及对心电图QT 间期的影响。3评估食物对健康成人单剂口服YZJ-3058 片后安全性和耐受性的影响。
第二阶段:多剂给药剂量递增(MAD)研究:
主要目的:评估健康成人空腹条件下多剂口服YZJ-3058 片后的安全性和耐受性。
次要目的:评估健康成人空腹条件下多剂口服YZJ-3058 片后YZJ-3058 及其代谢产物(如适用)的药代动力学特性。
[Translation] Phase I: Single-dose escalation (SAD) study + food effect (FE) study:
Primary objectives: 1 To evaluate the safety and tolerability of a single oral dose of YZJ-3058 tablets in healthy adults under fasting conditions. 2 To evaluate the pharmacokinetic properties of YZJ-3058 and its metabolites (if applicable) after a single oral dose of YZJ-3058 tablets in healthy adults under fasting conditions. 3 To evaluate the effect of food on the pharmacokinetic properties of a single oral dose of YZJ-3058 tablets in healthy adults.
Secondary objectives: 1 To evaluate the cumulative excretion rate of YZJ-3058 and its metabolites in urine and feces after a single oral dose of YZJ-3058 tablets in healthy adults under fasting conditions. 2 To evaluate the relationship between drug concentration-QT interval (C-QT) changes and the effect on the QT interval of the electrocardiogram after a single oral dose of YZJ-3058 tablets under fasting conditions. 3. Evaluate the effect of food on the safety and tolerability of a single oral dose of YZJ-3058 tablets in healthy adults.
Phase II: Multiple-dose escalation (MAD) study:
Primary objective: To evaluate the safety and tolerability of multiple oral doses of YZJ-3058 tablets in healthy adults under fasting conditions.
Secondary objective: To evaluate the pharmacokinetic properties of YZJ-3058 and its metabolites (if applicable) after multiple oral doses of YZJ-3058 tablets in healthy adults under fasting conditions.