[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, food effect, and pharmacokinetics of a single oral dose of RFUS-949 tablets in healthy Chinese subjects
主要目的:评价RFUS-949片在中国健康成年受试者中单次空腹口服给药的安全性、耐受性和药代动力学特征(Part A)。
次要目的:比较空腹和餐后状态下,中国健康受试者单次口服给药RFUS-949片的药代动力学特征,初步评估食物对RFUS-949暴露情况的影响(Part B)。
探索性目的:
1)初步探索RFUS-949片对中国健康受试者QTc间期的影响,即药物浓度-QTc(C-QTc)研究(Part A);
2)检测中国健康受试者血液、尿液和粪便中RFUS-949,并探索代谢产物(Part A)。
[Translation] Primary objective: To evaluate the safety, tolerability and pharmacokinetic characteristics of a single oral administration of RFUS-949 tablets in healthy Chinese adult subjects on an empty stomach (Part A).
Secondary objective: To compare the pharmacokinetic characteristics of a single oral administration of RFUS-949 tablets in healthy Chinese subjects in the fasting and fed states, and to preliminarily evaluate the effect of food on RFUS-949 exposure (Part B).
Exploratory objectives:
1) To preliminarily explore the effect of RFUS-949 tablets on the QTc interval of healthy Chinese subjects, i.e., drug concentration-QTc (C-QTc) study (Part A);
2) To detect RFUS-949 in the blood, urine and feces of healthy Chinese subjects, and to explore metabolites (Part A).