[Translation] A randomized, double-blind, placebo-controlled phase I clinical trial evaluating the safety, tolerability, and pharmacokinetics of TP1001 tablets in healthy participants after single and multiple doses, as well as the pharmacokinetics of food effects.
主要目的:评价中国健康参与者单次或多次口服 TP1001 片后的安全性和耐受性。
次要目的:1.评价中国健康参与者单次或多次口服 TP1001 片后的药代动力学特征;2.评价食物对中国健康参与者单次口服 TP1001 片后的药代动力学影响;3.评价中国健康参与者单次口服 TP1001 片后 TP1001 浓度对QT/QTC 间期的影响。
探索性目的:1.探索中国健康参与者单次口服 TP1001 片后可能的代谢产物及代谢途径;2.探索中国健康参与者单次口服 TP1001 片后可能的靶向生物标志物(Target Engagement Biomarker)
[Translation] Primary Objective: To evaluate the safety and tolerability of single or multiple oral administrations of TP1001 tablets in healthy Chinese participants.
Secondary Objectives: 1. To evaluate the pharmacokinetic characteristics of single or multiple oral administrations of TP1001 tablets in healthy Chinese participants; 2. To evaluate the pharmacokinetic effects of food on single oral administration of TP1001 tablets in healthy Chinese participants; 3. To evaluate the effect of TP1001 concentration on the QT/QTC interval after a single oral administration of TP1001 tablets in healthy Chinese participants.
Exploratory Objectives: 1. To explore the possible metabolites and metabolic pathways after a single oral administration of TP1001 tablets in healthy Chinese participants; 2. To explore potential target engagement biomarkers after a single oral administration of TP1001 tablets in healthy Chinese participants.