| Outcome Measures: |
Primary: Incidence of adverse events (AEs), Incidence of adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0., From patient enrollment to withdrawal, estimated up to 2 months.|Severity of adverse events, Severity of adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0., From patient enrollment to withdrawal, estimated up to 2 months.|Incidence of serious adverse events (SAEs), Incidence of serious adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0., From patient enrollment to withdrawal, estimated up to 2 months.|Severity of serious adverse events (SAEs), Severity of serious adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0., From patient enrollment to withdrawal, estimated up to 2 months. | Secondary: Peak concentration (Cmax), The highest blood drug concentration achieved after administration., SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|Plasma concentration-area under time curve (AUC0-t), The area under the plasma concentration-time curve from the beginning of the first administration to the last measurable concentration point., SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|Plasma concentration-area under time curve (AUC0-∞), Extrapolated from the first administration to the area under the plasma concentration-time curve to infinity., SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|Peak Time (Tmax), the time required to reach the highest concentration (peak drug concentration)., SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|Apparent volume of distribution (Vd/F), The theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma, SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|Clearance (CL), The volume of a substance in plasma that the body or organ can clear per unit time., SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|Elimination half-life time (t1/2), The time it takes to reduce the concentration of drugs in the blood by half., SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|Plasma concentration at steady state (Cav, SS), The plasma concentration at which the rate of administration and rate of elimination are in equilibrium., SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|Tmax, ss, Time required to reach steady-state peak concentration after administration, SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|Cmax, ss, The highest blood drug concentration that occurs after reaching steady state, SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|Cmin, ss, The lowest blood drug concentration that occurs after reaching steady state, SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|AUC, ss, The area under the plasma concentration-time curve of the steady state, SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|Rac, The ratio of steady-state blood drug concentration to blood drug concentration after the first administration, SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.|Anti-Drug Antibody (ADA), The incidence of ADA after drug administration for evaluating the immunogenicity of antibody drugs., SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
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