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.