[Translation] A randomized, double-blind, placebo-controlled, multiple-dose escalation phase IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ABP2111Na tablets in overweight/obese subjects
主要目的:
评价超重/肥胖受试者多次口服ABP2111Na片的安全性和耐受性;
次要目的:
1)评价超重/肥胖受试者多次口服ABP2111Na片的药代动力学(PK)特征;
2)评价超重/肥胖受试者多次口服ABP2111Na片药效动力学(PD);
3)初步探索ABP2111Na片控制体重的有效性,为后期临床研究提供依据;
4)初步评估ABP2111Na片在超重/肥胖受试者的心脏安全性,包括校正QT间期(QTc)延长的可能性,并评估PK/QTc关系。
[Translation] Main purpose:
Evaluate the safety and tolerability of ABP2111Na tablets after multiple oral administration in overweight/obese subjects;
Secondary purposes:
1) Evaluate the pharmacokinetic (PK) characteristics of ABP2111Na tablets after multiple oral administration in overweight/obese subjects;
2) Evaluate the pharmacodynamics (PD) of ABP2111Na tablets after multiple oral administration in overweight/obese subjects;
3) Preliminarily explore the effectiveness of ABP2111Na tablets in controlling body weight and provide a basis for later clinical studies;
4) Preliminarily evaluate the cardiac safety of ABP2111Na tablets in overweight/obese subjects, including the possibility of correcting the QT interval (QTc) prolongation, and evaluate the PK/QTc relationship.