[Translation] Phase I clinical trial of safety, tolerability, pharmacokinetic characteristics and food effects of single and multiple oral administration of XH-S002 in healthy adult subjects
主要研究目的:评估健康成人单次和多次服用 XH-S002 后的安全性和耐受性;
次要研究目的:
评估健康成人单次和多次服用 XH-S002 后的药代动力学(PK)特征;
评估食物对健康成人服用 XH-S002 后的 PK 的影响;
评估健康成人单次和多次服用 XH-S002 后的药效动力学(PD)特征;
探索性目的:
评估口服 XH-S002 后的 Concentration-QTc(C-QTc)相关性;
探索性分析 XH-S002 的 PK/PD 相关性。
[Translation] Primary study objectives: To evaluate the safety and tolerability of XH-S002 after single and multiple doses in healthy adults;
Secondary study objectives:
To evaluate the pharmacokinetic (PK) characteristics of XH-S002 after single and multiple doses in healthy adults;
To evaluate the effect of food on the PK of XH-S002 after single and multiple doses in healthy adults;
To evaluate the pharmacodynamic (PD) characteristics of XH-S002 after single and multiple doses in healthy adults;
Exploratory objectives:
To evaluate the Concentration-QTc (C-QTc) correlation after oral administration of XH-S002;
To conduct an exploratory analysis of the PK/PD correlation of XH-S002.