[Translation] A single-center, randomized, double-blind, placebo-controlled, single-dose and multiple-dose escalation clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and the effect of food on pharmacokinetics of APH04935 tablets in healthy adults and overweight or obese trial participants.
主要研究目的:评价APH04935片在健康成人试验参与者中单次口服给药(SAD)、以及在超重或肥胖试验参与者中多次口服给药(MAD)的安全性和耐受性。
次要研究目的:1)评价APH04935片在健康成人试验参与者中单次口服给药、以及在超重或肥胖试验参与者中多次口服给药的药代动力学特征;2)评价食物对健康成人试验参与者单次口服APH04935片药代动力学的影响;3)评价APH04935片在超重或肥胖试验参与者中多次口服给药后的药效学作用。
探索性研究目的:1)评价APH04935片在试验参与者中口服给药后对QT/QTc间期的影响;2)探索APH04935片在人体内的代谢情况;3)如数据允许,基于群体药代动力学(PopPK)分析方法,探索药物的暴露量与药效学(药效学指标、安全性指标)的关系。
[Translation] Primary Study Objective: To evaluate the safety and tolerability of APH04935 tablets after a single oral dose (SAD) in healthy adult participants and after multiple oral doses (MAD) in overweight or obese participants.
Secondary Study Objectives: 1) To evaluate the pharmacokinetic characteristics of APH04935 tablets after a single oral dose in healthy adult participants and after multiple oral doses in overweight or obese participants; 2) To evaluate the effect of food on the pharmacokinetics of APH04935 tablets after a single oral dose in healthy adult participants; 3) To evaluate the pharmacodynamic effects of APH04935 tablets after multiple oral doses in overweight or obese participants.
Exploratory Study Objectives: 1) To evaluate the effect of oral administration of APH04935 tablets on the QT/QTc interval in participants; 2) To explore the metabolism of APH04935 tablets in humans; 3) If data permit, to explore the relationship between drug exposure and pharmacodynamics (pharmacodynamic parameters, safety parameters) using population pharmacokinetic (PopPK) analysis.