[Translation] A randomized, double-blind, placebo-controlled, single- and multiple-dose escalation phase I clinical trial of TT-00920 in healthy subjects
主要目的:研究健康受试者单次和多次剂量递增口服TT-00920片的安全性和耐受性。
次要目的:确定健康受试者单次和多次口服给药后TT-00920及其主要代谢产物的血浆药物代谢动力学(Pharmacokinetics, PK)特征。
探索性目的:①探索健康受试者中单次和多次口服TT-00920片的血液及尿液中生物标志物变化;②探索健康受试者单次和多次口服给药后TT-00920及其主要代谢产物的尿液PK特征;③探索药物代谢酶的基因多态性
[Translation] Primary objective: To study the safety and tolerability of single and multiple ascending doses of TT-00920 tablets in healthy subjects.
Secondary objective: To determine the plasma pharmacokinetics (PK) characteristics of TT-00920 and its main metabolites after single and multiple oral administration in healthy subjects.
Exploratory objectives: ① To explore the changes in biomarkers in blood and urine after single and multiple oral administration of TT-00920 tablets in healthy subjects; ② To explore the urine PK characteristics of TT-00920 and its main metabolites after single and multiple oral administration in healthy subjects; ③ To explore the genetic polymorphism of drug metabolizing enzymes