[Translation] A Pivotal, Open-Label, Multicenter, Safety and Pharmacokinetic Study of MB-102 (Relmapirazin) and the MediBeacon® Transcutaneous Glomerular Filtration Rate Dynamic Monitoring System for Renal Function Assessment in Normal and Renally Impaired Subjects
1、旨在表明使用 MediBeacon® 经皮肾小球滤过率动态监测系统测量的 MB-102 经皮荧光 GFR 与 MB-102 血浆 GFR的一致性
2、旨在评估单剂量 MB-102 用于受试者的安全性和耐受性
3、旨在受试者中,评估使用 MediBeacon® 经皮肾小球滤过率动态监测系统经皮无创监测 MB-102 荧光的安全性和有效性
[Translation] 1. To demonstrate the consistency between MB-102 transcutaneous fluorescence GFR measured by MediBeacon® transcutaneous glomerular filtration rate dynamic monitoring system and MB-102 plasma GFR
2. To evaluate the safety and tolerability of single-dose MB-102 in subjects
3. To evaluate the safety and effectiveness of non-invasive transcutaneous monitoring of MB-102 fluorescence using MediBeacon® transcutaneous glomerular filtration rate dynamic monitoring system in subjects