[Translation] A randomized, double-blind, placebo-controlled single-dose, multiple-dose ascending study and food effect study to evaluate the safety, tolerability, pharmacokinetic characteristics and food effect of ISM5411 in healthy Chinese subjects
主要目的:
评估ISM5411单次和多次口服给药在中国健康受试者中的安全性和耐受性。
次要目的:
评估ISM5411单次和多次口服给药后,ISM5411和M15(ISM5411代谢物)在中国健康受试者中的药代动力学(Pharmacokinetics,PK)特征。
评估食物在中国健康受试者单次服用ISM5411后,对ISM5411和M15(ISM5411代谢物)PK特性的影响。
探索性目的:
评估ISM5411单次和多次口服给药后,中国健康受试者外周血生物标志物(促红细胞生成素和血管内皮生长因子)和粪便生物标志物(钙卫蛋白和脂质运载蛋白-2)的表达变化。
[Translation] Primary objectives:
To evaluate the safety and tolerability of single and multiple oral administration of ISM5411 in healthy Chinese subjects.
Secondary objectives:
To evaluate the pharmacokinetic (PK) characteristics of ISM5411 and M15 (metabolite of ISM5411) in healthy Chinese subjects after single and multiple oral administration of ISM5411.
To evaluate the effect of food on the PK characteristics of ISM5411 and M15 (metabolite of ISM5411) after a single dose of ISM5411 in healthy Chinese subjects.
Exploratory objectives:
To evaluate the changes in the expression of peripheral blood biomarkers (erythropoietin and vascular endothelial growth factor) and fecal biomarkers (calprotectin and lipocalin-2) in healthy Chinese subjects after single and multiple oral administration of ISM5411.