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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab injection | Experimental | On the first day, bevacizumab injection was given, 3mg/kg each time, diluted to 100ml of 0.9% sodium chloride injection, mixed evenly, and then intravenous infusion for 90 minutes (±15 minutes). |
|
| Bevacizumab injection(Avastin) | Active Comparator | On the first day, Avastin injection was given, 3mg/kg of which was diluted to 100ml of 0.9% sodium chloride injection. After mixing evenly, it was infused intravenously for 90 minutes (±15 minutes). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab injection | Drug | Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 30 minutes before administration to 1680 hours (day 71) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration-area under time curve(AUC0-∞) | Area under the blood concentration time curve from 0 hour to inf (infinity) | Within 30 minutes before administration to 1680 hours (day 71) |
| Peak concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Changchun University of Traditional Chinese Medicine | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D008175 | Lung Neoplasms |
| D010051 | Ovarian Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab injection(Avastin) | Drug | Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor |
|
Maximum plasma concentration observed after administration
| Within 30 minutes before administration to 1680 hours (day 71) |
| Incidence of adverse events | Incidence of adverse events assessed by CTCAE v4.0 | 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 | 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 | 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 | Within 30 minutes before administration to 1680 hours (day 71) |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |