[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, food effect, and QT/QTc of VB19055 tablets in healthy Chinese adults
主要目的:评估单、多次口服VB19055片在健康受试者中的安全性和耐受性。
次要目的:评估单、多次口服VB19055片在健康受试者中药代动力学(PK)特征。评价食物对健康受试者单次口服VB19055片后PK特征的影响。评估VB19055片在中国健康受试者中单次和多次口服给药后的药效学(PD)特征。
探索性目的:初步评估VB19055片对健康受试者QT/QTc间期的影响。探索性研究健康受试者口服VB19055片后的代谢产物。
[Translation] Primary Objective: To evaluate the safety and tolerability of single and multiple oral doses of VB19055 tablets in healthy subjects.
Secondary Objective: To evaluate the pharmacokinetic (PK) profile of single and multiple oral doses of VB19055 tablets in healthy subjects. To assess the effect of food on the PK profile of VB19055 tablets after single oral administration in healthy subjects. To evaluate the pharmacodynamic (PD) profile of VB19055 tablets after single and multiple oral doses in healthy Chinese subjects.
Exploratory Objective: To preliminarily evaluate the effect of VB19055 tablets on the QT/QTc interval in healthy subjects. To conduct an exploratory study of the metabolites of VB19055 tablets after oral administration in healthy subjects.