[Translation] A Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and food effects of single-dose and multiple-dose escalation of KR23343 tablets in healthy adult subjects in China.
主要试验目的:
考察健康成人受试者单次、多次口服KR23343片的安全性和耐受性。
次要试验目的:
1.评价健康成人受试者单次、多次口服KR23343片的药代动力学(Pharmacokinetic,PK)特征; 2.评价食物对健康成人受试者单次口服KR23343片后PK特征及安全性的影响;
3.观察健康成人受试者服用不同剂量KR23343片后对经校正的QTcF和其它ECG参数的影响。
[Translation] Primary objective: To investigate the safety and tolerability of single and multiple oral doses of KR23343 tablets in healthy adult subjects.
Secondary objectives:
1. To evaluate the pharmacokinetic (PK) characteristics of single and multiple oral doses of KR23343 tablets in healthy adult subjects;
2. To evaluate the effect of food on the PK characteristics and safety of single oral doses of KR23343 tablets in healthy adult subjects;
3. To observe the effects of different doses of KR23343 tablets on corrected QTcF and other ECG parameters in healthy adult subjects.