Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor (bevacizumab) is Avastin produced by Zhengda Tianqing Pharmaceutical Group Co., Ltd Biological similar drugs. Its mechanism is to prevent VEGF from binding to its natural receptor VEGFR, inhibit the proliferation and activation of vascular endothelial cells, and play an anti angiogenesis and anti-tumor role by binding with VEGF. A randomized, double-blind, single dose, parallel comparison of bevacizumab injection and Avastin is planned The phase I clinical study on the similarity of pharmacokinetics and safety of traditional Chinese medicine in healthy male volunteers aims to compare bevacizumab injection with Avastin The similarity of pharmacokinetics, tolerance, safety and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
98
Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor
Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, China
Plasma concentration-area under time curve(AUC0-t)
Area under the blood concentration time curve from 0 hour to the collection time t of the last measurable concentration
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
Plasma concentration-area under time curve(AUC0-∞)
Area under the blood concentration time curve from 0 hour to inf (infinity)
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
Peak concentration (Cmax)
Maximum plasma concentration observed after administration
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
Incidence of adverse events
Incidence of adverse events assessed by CTCAE v4.0
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
Number of adverse events related to the study drug
Number of adverse events evaluated by CTCAE v4.0
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
Incidence of adverse events related to the study drug
Incidence of study drug-related adverse events assessed by CTCAE v4.0
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
ADA positive rate
When anti drug antibody (ADA) is positive, neutralizing antibody (NAB) test is performed
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.