[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalating Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of LD2020 enteric-coated tablets in healthy Chinese adult volunteers
主要目的:(1)评估LD2020 肠溶片在中国健康成年志愿者中单次口服给药剂量递增的安全性和耐受性。(2)评估LD2020 肠溶片在中国健康成年志愿者中多次口服给药的安全性和耐受性。次要目的:(1)评估LD2020 肠溶片在中国健康成年志愿者中单次及多次口服给药后的药代动力学(PK)特征;进行LD2020 人体物料平衡的初步探索。(2)评估食物(高脂高热量餐)对LD2020 肠溶片PK 的影响。(3)初步评估LD2020 肠溶片对志愿者QT/QTc 间期的影响。
[Translation] Primary objectives: (1) To evaluate the safety and tolerability of LD2020 Enteric-coated Tablets after single oral dose escalation in healthy Chinese adult volunteers. (2) To evaluate the safety and tolerability of LD2020 Enteric-coated Tablets after multiple oral doses in healthy Chinese adult volunteers. Secondary objectives: (1) To evaluate the pharmacokinetic (PK) characteristics of LD2020 Enteric-coated Tablets after single and multiple oral doses in healthy Chinese adult volunteers; to conduct a preliminary exploration of the material balance of LD2020 in humans. (2) To evaluate the effect of food (high-fat, high-calorie meal) on the PK of LD2020 Enteric-coated Tablets. (3) To preliminarily evaluate the effect of LD2020 Enteric-coated Tablets on the QT/QTc interval of volunteers.