[Translation] A randomized, double-blind, placebo-controlled Phase Ia clinical study evaluating the safety, tolerability, and pharmacokinetics (PK) of a single dose of H029 tablets in healthy adult participants, as well as the effects of food.
1、研究健康成年试验参与者单次口服 H029 片的安全性和耐受性;
2、观察健康成年试验参与者单次口服 H029 片的人体 PK 特征,为后期临床研究的剂量选择提供依据;
3、探索饮食对 H029 的 PK 和安全性的影响 研究饮食(高脂餐)对健康成年试验参与者口服 H029 片安全性、耐受性以及对 PK 的影响
[Translation] 1. To investigate the safety and tolerability of a single oral dose of H029 tablets in healthy adult participants;
2. To observe the pharmacokinetic (PK) characteristics of a single oral dose of H029 tablets in healthy adult participants, providing a basis for dose selection in future clinical studies;
3. To explore the effects of diet on the PK and safety of H029, studying the effects of diet (high-fat meal) on the safety, tolerability, and PK of oral H029 tablets in healthy adult participants.