The trial was designed as a single-center, randomized, double-blind, single-dose parallel controlled phase I study to evaluate the similarity of pharmacokinetics and safety of Meperizumab injection and NUCALA® in healthy male volunteers. The plan is to enroll 88 healthy subjects. After signing the written informed consent voluntarily, the subjects will undergo a series of examinations and information collection to determine whether they meet the inclusion criteria. The qualified subjects will be randomized and administered. Biological samples were collected and safety checked before and after administration according to protocol requirements. Adverse events occurred during the trial were collected, and the combination of drug use and non-drug treatment were asked and recorded in detail. When the 90% confidence interval of geometric mean ratio of the main pharmacokinetic parameters of Meperizumab injection and NUCALA® was within the range of 80.00%-125.00%, it was proved that the pharmacokinetic characteristics of the two were similar.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
88
Meperizumab injection is a humanized monoclonal antibody of IgG1 injection
NUCALA® is a humanized monoclonal antibody of IgG1 injection
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, China
Peak concentration(Cmax)
Peak maximum plasma drug concentration
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Area under drug concentration - time curve(AUC0-t)
Area under the curve from zero to the lowest detectable blood drug concentration
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
The area under the curve extrapolating from zero to infinity(AUC0-∞)
Area under the curve from zero to infinity
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Peak concentration time(Tmax)
Time to reach maximum plasma concentration after dosing
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
half-life(T1/2)
The time it takes for serum drug concentrations to drop by half
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Elimination rate constant(λz)
The slope of the terminal segment of a semi-logarithmic curve
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Residual area percentage(AUC%Extrap)
The percentage of the difference between AUC0-∞ and AUC0-t as a percentage of AUC0-t
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Apparent clearance(CL/F)
Percentage of the body that eliminates organ-scavenging drugs
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Apparent volume of distribution(Vd/F)
Apparent volume of distribution after non-intravenous administration
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Physical examination
The doctor will percuss, look, and question the subject, and record any abnormalities in the skin, spine, or limbs
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Body temperature
Abnormal body temperature
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Pulse
Abnormal pulse
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Blood pressure
Abnormal blood pressure
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Electrocardiogram(ECG) QT Interval
Abnormal ECG QT Interval
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Anti-drug antibody(ADA)
ADA positive
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Neutralizing antibody(NAb)
NAb positive
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
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