[Translation] A single-center, randomized, double-blind, placebo-controlled, single-dose and multiple-dose escalation clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects on pharmacokinetics of APH03867 tablets in healthy adult participants.
主要研究目的:
评价健康成人单次和多次口服APH03867片的安全性和耐受性
次要研究目的:
评价健康成人单次和多次口服APH03867片的药代动力学特征
评价食物对健康成人单次口服APH03867片药代动力学的影响
探索性研究目的:
评价APH03867片在健康成人口服后对QT/QTc间期的影响
探索APH03867片在人体内的代谢情况
评价健康成人口服APH03867后药效学作用
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 Objectives:
Evaluate the safety and tolerability of single and multiple oral doses of APH03867 tablets in healthy adults.
Secondary Study Objectives:
Evaluate the pharmacokinetic characteristics of single and multiple oral doses of APH03867 tablets in healthy adults.
Evaluate the effect of food on the pharmacokinetics of a single oral dose of APH03867 tablets in healthy adults.
Exploratory Study Objectives:
Evaluate the effect of APH03867 tablets on the QT/QTc interval after oral administration in healthy adults.
Investigate the metabolism of APH03867 tablets in the human body.
Evaluate the pharmacodynamic effects of oral APH03867 in healthy adults.
If data permit, explore the relationship between drug exposure and pharmacodynamics (pharmacodynamic parameters, safety parameters) using population pharmacokinetic (PopPK) analysis.