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.