Study procedures
biochemistry and coagulation function
ADVERSE EVENTS
Both JMB2002 and placebo were diluted in a 0.9% sodium chloride (250 mL), and then were perfused intravenously for 60 min. First 10 participants were randomized (4:1) to receive 5 mg/kg of JMB2002 or placebo in cohort 1, and monitored for adverse events. After a successful safety evaluation on Day 7, the cohort 2 was proceeded with another 10 randomly-selected participants receiving 15 mg/kg of JMB2002 or placebo (4:1), and so on. Particularly in cohort 3 (30 mg/kg) and 4 (50 mg/kg), two sentinels were first randomly selected and assigned (1:1) to receive JMB2002 or placebo respectively; and only if there were no drug-related AEs ≥ graded 3 after day 1, the remaining 8 participants were proceeded.Vital signs, such as blood pressure, pulse, respiration and ear temperature, were taken at 0 h as baseline, then 1, 3, 8, 24, 48, and 72 h after administration and on days 8, 15, 29, 43, 57, and 85 or early termination day. Physical examination, including skin, mucous membrane, lymph node and so on, was taken on days 8, 29,57 and 85 or early termination day. Laboratory examination, including blood routine, urine routine, blood biochemistry and coagulation function, and 12-lead electrocardiogram were carried out on days 4,8,29,57 and 85 or early termination day.