2.2 Design
A Phase I, single and continuous administration study of safety, tolerability and pharmacokinetics of EH by intravenous injection in healthy subjects was conducted. The study, sponsored by Beijing SH Biotechnology Co., Ltd. and Beijing Institute of Radiation Medicine, was performed at the Phase I Unit of Beijing You’an Hospital, Capital Medical University. Both studies were approved by applicable institutional review boards/ethics committees and conducted in accordance with country regulations, the International Conference on Harmonisation Good Clinical Practice guidelines, and the principles of the Declaration of Helsinki. Written informed consent was obtained from all subjects.