Outcomes
anomaly
ADVERSE EVENTS, EVENTS
The primary outcome was the safety and tolerability of the JMB2002 in healthy Chinese adults, which was quantified by the number and proportion of treatment emergent adverse events (TEAEs). Any anomaly in the exam results and occurred adverse medical events were also recorded. Secondary outcomes were pharmacokinetic characteristics and immunogenicity. Pharmacokinetic parameters were calculated and analyzed using non-compartmental analysis (Phoenix WinNonlin version 6.4 or above), by measuring the concentration of JMB2002 in serum of participants at 0 h as baseline, then 1, 3, 8, 24, 48 and 72 h, and on days 8, 15, 29, 43, 57 and 85 after receiving a single dose of JMB2002 by intravenous infusion. The area under the serum concentration–time curve from time zero to the time of the last quantifiable concentration (AUC