[Translation] Evaluation of the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of FCN-207 tablets in healthy volunteers: a single-center, randomized, double-blind, placebo-controlled, single-dose and multiple-dose ascending phase I clinical study
主要目的:
研究健康志愿者单次和多次服用FCN-207片后的安全性和耐受性。
次要目的:
观察健康志愿者单次服用FCN-207片后的药代动力学和药效学特征;
观察健康志愿者多次服用FCN-207片后的药代动力学和药效学特征;
评估食物对健康志愿者口服FCN-207片人体药动学特征的影响;
评估健康志愿者口服FCN-207片后的代谢与排泄特征(血浆和尿液);
探索性目的:
评估健康志愿者口服FCN-207片后的代谢与排泄特征(粪便);
评估健康志愿者口服FCN-207片后的C-QTc、群体PKPD、暴露-效应(ER)关系。
[Translation] Primary objective:
To study the safety and tolerability of FCN-207 tablets after single and multiple administration in healthy volunteers.
Secondary objectives:
To observe the pharmacokinetic and pharmacodynamic characteristics of FCN-207 tablets after single administration in healthy volunteers;
To observe the pharmacokinetic and pharmacodynamic characteristics of FCN-207 tablets after multiple administration in healthy volunteers;
To evaluate the effect of food on the pharmacokinetic characteristics of FCN-207 tablets in healthy volunteers;
To evaluate the metabolism and excretion characteristics (plasma and urine) of FCN-207 tablets after oral administration in healthy volunteers;
Exploratory objectives:
To evaluate the metabolism and excretion characteristics (feces) of FCN-207 tablets after oral administration in healthy volunteers;
To evaluate the C-QTc, population PKPD, and exposure-effect (ER) relationship of FCN-207 tablets after oral administration in healthy volunteers.