[Translation] A single-center, randomized, double-blind, placebo-controlled, single- and multiple-dose, dose-escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and food effects of oral FM888 capsules in healthy Chinese adult subjects
主要目的 评估健康成人空腹单次和多次口服FM888胶囊后的安全性、耐受性。
次要目的 评估健康成人空腹单次和多次口服FM888胶囊后的药代动力学特征。 评估食物对健康成人口服FM888胶囊后的药代动力学特征的影响。 健康成人空腹单次口服FM888胶囊600mg后的代谢产物分析及鉴定。
[Translation] Primary objective To evaluate the safety and tolerability of FM888 capsules after single and multiple oral administration in healthy adults on an empty stomach.
Secondary objective To evaluate the pharmacokinetic characteristics of FM888 capsules after single and multiple oral administration in healthy adults on an empty stomach. To evaluate the effect of food on the pharmacokinetic characteristics of FM888 capsules after oral administration in healthy adults. To analyze and identify the metabolites of FM888 capsules 600 mg after a single oral administration in healthy adults on an empty stomach.