[Translation] A single-center, randomized, double-blind, placebo-controlled, phase Ia clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of single/multiple dose escalation of ABP2111Na tablets in healthy subjects
主要目的:
评价健康成年受试者单次/多次口服不同剂量ABP2111Na片的安全性和耐受性。
次要目的:
1)评价健康成年受试者单次/多次口服不同剂量ABP2111Na片的药代动力学(PK)特征;
2)评价健康成年受试者多次口服不同剂量ABP2111Na片的药效动力学(PD)特征;
3)在特定剂量组内探索食物对ABP2111Na片PK特征及安全性的影响;
4)初步评估ABP2111Na片的心脏安全性,包括校正QT间期(QTc)延长的可能性,并评估PK/QTc关系。
[Translation] Primary objective:
To evaluate the safety and tolerability of ABP2111Na tablets in healthy adult subjects after single/multiple oral administration of different doses.
Secondary objectives:
1) To evaluate the pharmacokinetic (PK) characteristics of ABP2111Na tablets in healthy adult subjects after single/multiple oral administration of different doses;
2) To evaluate the pharmacodynamic (PD) characteristics of ABP2111Na tablets in healthy adult subjects after multiple oral administration of different doses;
3) To explore the effect of food on the PK characteristics and safety of ABP2111Na tablets in specific dose groups;
4) To preliminarily evaluate the cardiac safety of ABP2111Na tablets, including the possibility of correcting the QT interval (QTc) prolongation, and to evaluate the PK/QTc relationship.