[Translation] A randomized, double-blind, placebo-controlled, single-dose and multiple-dose-escalation phase I clinical study evaluating the safety, tolerability, and pharmacokinetic characteristics of oral administration of YY524051 tablets in healthy trial participants.
主要目的: 评价健康试验参与者单次及多次口服YY524051片的安全性和耐受性。
次要目的:① 评价健康试验参与者单次及多次口服YY524051片后的药代动力学(PK)特征;② 评价健康试验参与者于高脂餐条件下单次口服YY524051片后的PK特征;③ 评价健康试验参与者单次口服YY524051片对QT/QTc间期的影响。
探索性目的: 评价YY524051片在健康试验参与者中多次给药后的探索性指标。
[Translation] Primary Objective: To evaluate the safety and tolerability of single and multiple oral doses of YY524051 tablets in healthy participants.
Secondary Objectives: ① To evaluate the pharmacokinetic (PK) characteristics of single and multiple oral doses of YY524051 tablets in healthy participants; ② To evaluate the PK characteristics of a single oral dose of YY524051 tablets under high-fat meal conditions in healthy participants; ③ To evaluate the effect of a single oral dose of YY524051 tablets on the QT/QTc interval in healthy participants.
Exploratory Objective: To evaluate exploratory endpoints of YY524051 tablets after multiple administrations in healthy participants.