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.