5 Conclusions
The results of this study showed that the EH had good tolerance and safety in Chinese healthy subjects, but the safety and pharmacodynamics of this drug need to be further studied in thrombotic patients. No dose-limiting toxicity occurred, no deaths, no serious adverse events and serious adverse reactions, no adverse events and adverse reactions leading to withdrawal, and most adverse reactions returned to normal without intervention. In summary, the tolerance and PK characteristics of EH support that phase II clinical trials of this drug is performed and the recommended doses of EH are: 4-11.2mg/kg, and the recommended way of administration is first intravenous bolus injection of 0.4mg/kg, and then the dose is maintained at 0.15-0.45mg/kg/h, intravenous drip.
ACKNOWLEDGEMENTS
This study was partially supported by the grant from the Chinese National Major Projects for New Drug Discovery (No.2018ZX09301010-001).
COMPETING INTERESTS
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
CONTRIBUTORS
Conception and design: Wu Chu-tse and Jin Ji-De
Operation of clinical experiments/acquisition of data: Liu Yu-Bin, Wang Mei-Xia, He Jia, Zhang Lin, Zhou Ying, Xia Xia
Analysis of pharmacodynamics: Dong Xiao-Na and Dou Gui-Fang
Analysis and interpretation of data: All authors.
Drafting the manuscript or revising it critically for important intellectual content: all authors.
DATA AVAILABILITY STATEMENT
The clinical data that support the findings of this study are available from the corresponding author, in agreement with Beijing Institute of Radiation Medicine, upon reasonable request.