A phase I trial for the tolerability of Aoshaen injection

Objective: To assess the safety and tolerance of Aoshaen injection in Chinese healthy volunteers.Methods: Healthy volunteers(n=40) were randomly divided into either single-dose or multiple-doses group.In the single dose group,Aoshaen was intravenously dripped at dose of30,60,100,150,200 or 250mg.In the multiple-dose group,it was intravenously dripped at 200mg once daily for 7 days.The safety profiles and tolerability were evaluated based on vital signs,routine blood and urine tests,hepatic and renal functions,blood electrolytes,and electrocardiogram and incidence of adverse events.Results: Aoshaen injection induced a temporary drop in blood pressure,but did not induce any significant changes in all laboratory and physical examinations in both groups.Common adverse events included flushing,dizziness,headache,nausea,and sweating;hypertemperature,palpitation,and bellyache were occasionally observed in few subjects.Conclusion: Aoshaen injection shows better safety profile and tolerability in the dosage we observed in this phase I trial.