[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of HHT120 capsules in healthy subjects with single and multiple dose escalation and the effect of food on PK
主要研究目的:
评价健康受试者单次及多次服用HHT120胶囊后的安全性、耐受性。
次要研究目的:
评价健康受试者单次及多次服用HHT120胶囊后的药代动力学特征;
评价健康受试者单次及多次服用HHT120胶囊后的药效动力学特征;
评价健康受试者单次及多次服用HHT120胶囊后血药浓度与药效动力学的相关性;
评价健康受试者空腹及餐后状态下服用HHT120胶囊的药代动力学特征,评价食物对药代动力学特征的影响。
探索性目的:
健康受试者单次服用HHT120胶囊后人体内的主要代谢产物鉴定;
健康受试者单次及多次服用HHT120胶囊后对QT间期的影响。
[Translation] Main research objectives:
Evaluate the safety and tolerability of HHT120 capsules after single and multiple doses in healthy subjects.
Secondary research objectives:
Evaluate the pharmacokinetic characteristics of HHT120 capsules after single and multiple doses in healthy subjects;
Evaluate the pharmacodynamic characteristics of HHT120 capsules after single and multiple doses in healthy subjects;
Evaluate the correlation between blood drug concentration and pharmacodynamics after single and multiple doses of HHT120 capsules in healthy subjects;
Evaluate the pharmacokinetic characteristics of HHT120 capsules in healthy subjects in fasting and postprandial states, and evaluate the effect of food on pharmacokinetic characteristics.
Exploratory objectives:
Identification of the main metabolites in the human body after a single dose of HHT120 capsules in healthy subjects;
The effect of single and multiple doses of HHT120 capsules on the QT interval in healthy subjects.