[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SAL0140 tablets in Chinese adult healthy study participants
主要目的: 评价 SAL0140 片在中国成年健康研究参与者中单次和多次给药的安全性和耐受性。
次要目的:
评价 SAL0140 片在中国成年健康研究参与者中单次和多次给药的药代动力学特征;
评价 SAL0140 片在中国成年健康研究参与者中单次和多次给药的药效学特征[药效学指标包括血浆醛固酮、尿液醛固酮等];
初步评价食物对 SAL0140 片在中国成年健康研究参与者中药代动力学特征的影响;
通过 C-QTc 模型化分析,评价 SAL0140 对 QT 间期的影响。
[Translation] Primary objective: To evaluate the safety and tolerability of single and multiple doses of SAL0140 tablets in Chinese adult healthy study participants.
Secondary objectives:
To evaluate the pharmacokinetic characteristics of single and multiple doses of SAL0140 tablets in Chinese adult healthy study participants;
To evaluate the pharmacodynamic characteristics of single and multiple doses of SAL0140 tablets in Chinese adult healthy study participants [pharmacodynamic indicators include plasma aldosterone, urine aldosterone, etc.];
To preliminarily evaluate the effect of food on the pharmacokinetic characteristics of SAL0140 tablets in Chinese adult healthy study participants;
To evaluate the effect of SAL0140 on the QT interval through C-QTc modeling analysis.