[Translation] A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and food effects of TRD205 after single and multiple doses in healthy adult subjects
主要目的:
单次给药剂量递增研究:
1.评价健康受试者在空腹状态下单次口服TRD205的安全性和耐受性
2.评价健康受试者在空腹状态下单次口服TRD205的药代动力学特征
3.确定最大耐受剂量
多次给药剂量递增研究:
1.评价健康受试者在空腹状态下多次口服TRD205的安全性和耐受性
2.评价健康受试者在空腹状态下多次口服TRD205的药代动力学特征
3.确定最大耐受剂量
食物影响研究:
1.探索食物对TRD205体内暴露的影响
[Translation] Main purpose:
Single-dose escalation study:
1. Evaluate the safety and tolerability of a single oral administration of TRD205 in healthy subjects in the fasting state
2. Evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects in the fasting state
3. Determine the maximum tolerated dose
Multiple-dose escalation study:
1. Evaluate the safety and tolerability of multiple oral administration of TRD205 in healthy subjects in the fasting state
2. Evaluate the pharmacokinetic characteristics of multiple oral administration of TRD205 in healthy subjects in the fasting state
3. Determine the maximum tolerated dose
Food effect study:
1. Explore the effect of food on the in vivo exposure of TRD205