2.2.2 Single dose regimen
In the single-dose trial, 4 subjects were enrolled in the preliminary
trial, and 40 subjects were enrolled in the formal trial. In the
preliminary trial, considering that the test drug was first used in
humans, in order to protect the safety of the subjects to the utmost
extent, at the beginning of the preliminary trial (test drug 0.2mg/kg),
1 healthy subject was enrolled and observed for 7 days to confirm the
safety of EH,then the remaining 3 subjects were re-entered and observed
for 7 days. In the formal trial, the randomized, placebo-controlled,
dose-escalating study was divided into 5 dose group, 8 cases per group
(Test drug: placebo=6:2), and the order of increasing dose was: 0.4,
0.8, 1.2, 1.6, 2.0 mg/kg per administration. The research center
determined the drug grouping information of the subjects according to
the random system. The single administration process was shown in Figure
1.