[Translation] A randomized, double-blind, placebo-controlled, single/multiple dose escalation and food-effect Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of WBD156 capsules in healthy subjects and overweight/obese subjects
主要目的:评估 WBD156 胶囊在健康受试者及超重/肥胖受试者中的安全性和耐受性。
次要目的:1.评估 WBD156 胶囊在健康受试者及超重/肥胖受试者中的药代动力学(PK)特征;2. 评估 WBD156 胶囊在健康受试者及超重/肥胖受试者中的药效动力学(PD)特征;3.评估食物对 WBD156 胶囊的药代动力学(PK)影响(仅 20 mg 组);4.评估 WBD156胶囊在超重/肥胖受试者中的初步疗效;5. 初步评估 WBD156 胶囊在人体内的代谢情况。
探索性目的:初步探索 WBD156 胶囊对按心率校正的 QT 间期(QTc)的影响。
[Translation] Primary Objective: To evaluate the safety and tolerability of WBD156 Capsules in healthy subjects and overweight/obese subjects.
Secondary Objectives: 1. To evaluate the pharmacokinetic (PK) characteristics of WBD156 Capsules in healthy subjects and overweight/obese subjects; 2. To evaluate the pharmacodynamic (PD) characteristics of WBD156 Capsules in healthy subjects and overweight/obese subjects; 3. To evaluate the effect of food on the pharmacokinetic (PK) of WBD156 Capsules (20 mg group only); 4. To evaluate the preliminary efficacy of WBD156 Capsules in overweight/obese subjects; 5. To preliminarily evaluate the metabolism of WBD156 Capsules in humans.
Exploratory Objective: To preliminarily explore the effect of WBD156 Capsules on the QT interval corrected for heart rate (QTc).