[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and QTc effect research
主要目的:
评价单次/多次口服ZL-82片在健康人体内的安全性和耐受性。
次要目的:
1) 评价单次/多次口服ZL-82片在健康人体内的药代动力学(PK)特征。
2) 评价单次/多次口服ZL-82片在健康人体内的药效学(PD)特征。
3) 评价ZL-82片单剂量给药后对健康受试者QT/QTc间期的影响。
4) 评价ZL-82片给药后对健康受试者ECG参数(ΔQTcF/ΔΔQTcF以及HR、PR、QRS间期)的影响,以及对T波形态和U波的影响
[Translation] main purpose:
To evaluate the safety and tolerability of single/multiple oral doses of ZL-82 tablets in healthy humans.
Secondary purpose:
1) Evaluate the pharmacokinetic (PK) characteristics of single/multiple oral doses of ZL-82 tablets in healthy humans.
2) Evaluate the pharmacodynamic (PD) characteristics of single/multiple oral doses of ZL-82 tablets in healthy humans.
3) To evaluate the effect of ZL-82 tablets on QT/QTc interval in healthy subjects after single-dose administration.
4) Evaluate the effect of ZL-82 tablets on ECG parameters (ΔQTcF/ΔΔQTcF and HR, PR, QRS intervals) in healthy subjects, as well as the effect on T wave morphology and U wave