Yun Liu, Wei Wang, Hongjie Qian, Yuzhou Gui, Yating Wang, Rong Song, Qian Chen, Eric Rowinsky, Sheng Wang, Xiaoguang Liang, Kaicun Gu, Bo Zhou, Weiwei Zhang, Liqin Zhang, Chen Yu, Jingying Jia
This study evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and food effects (FE) of SC0062, a highly active endothelin-A (ETA ) receptor antagonist, in healthy subjects. The primary objectives of this first-in-human phase I study, comprised of single-ascending-dose, multiple-ascending-dose, and FE parts, were to characterize the safety and tolerability of SC0062, and FE. The secondary objectives were to determine the PK behavior of SC0062 and its major active metabolite M18, whereas exploratory objectives focused on PD effects, principally effects on endothelin-1 (ET-1) and total bile acids (TBA)...
March 2024: Clinical and Translational Science