[Translation] A single-center, randomized, double-blind study evaluating the safety, tolerability, pharmacokinetic characteristics, and food effects of single and multiple oral administrations of KBD104409 tablets in healthy subjects.
主要目的:
评价健康参与者单次、多次口服KBD104409片的安全性和耐受性。
次要目的:
评价健康参与者单次、多次口服KBD104409片的药代动力学(PK)特征。
评价健康参与者单次、多次口服KBD104409片对QTc间期的影响。
评价食物对健康参与者单次口服KBD104409片的药代动力学影响。
探索性目的:
评价健康参与者单次、多次口服KBD104409片的药效动力学(PD)特征。
分析KBD104409片在人体内的代谢产物(如适用)。
[Translation] Primary Objective: To evaluate the safety and tolerability of single and multiple oral doses of KBD104409 tablets in healthy participants.
Secondary Objectives: To evaluate the pharmacokinetic (PK) characteristics of single and multiple oral doses of KBD104409 tablets in healthy participants.
To evaluate the effect of single and multiple oral doses of KBD104409 tablets on the QTc interval in healthy participants.
To evaluate the effect of food on the pharmacokinetic characteristics of a single oral dose of KBD104409 tablets in healthy participants.
Exploratory Objective: To evaluate the pharmacodynamic (PD) characteristics of single and multiple oral doses of KBD104409 tablets in healthy participants.
To analyze the metabolites of KBD104409 tablets in humans (if applicable).