Xianglei Gao, Yujing Di, Yuan Lv, Yingcai Luan, Yang Xiong, Yuli Xu, Yusheng Li, Linfeng Guo, Xiaoping Li, Li Deng, Yulei Zhuang, Jie Hou
This study aimed to evaluate the pharmacokinetics (PKs), safety, and immunogenicity of the biosimilar HEC14028 compared to reference Trulicity® (dulaglutide) in healthy male Chinese subjects. This study was a single-center, randomized, open, single-dose, parallel-controlled comparative Phase I clinical trial, including a screening period of up to 14 days, a 17-day observation period after administration, and a 7-day safety follow-up period. A total of 68 healthy male subjects were randomly assigned (1:1) to the test group (HEC14028) and the reference group (dulaglutide) (single 0...
April 2024: Clinical and Translational Science