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The primary objective of this study is to evaluate the similarity of the primary pharmacokinetic (PK) parameter AUC0-t of GB222 and bevacizumab after single administration; the secondary objective is to observe the safety and similarities and safety of other pharmacokinetic (PK) parameters (Cmax, AUC0-∞ etc.) and immunogenicity of GB222 and bevacizumab after single administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GB222 | Experimental | 1mg/kg |
|
| Bevacizumab | Active Comparator | 1mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB222 | Biological | Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is > 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0- t | AUC 0- t | Up to 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Cmax | Up to 84 days |
| AUC0-∞ | AUC0-∞ | Up to 84 days |
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Exclusions:
male only
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shawn Yu, Master | Contact | 18600332657 | shawn.yu@genorbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Fang, Master | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Peking University | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract 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 | Biological | Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is > 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time. |
|
|
| ADA |
ADA |
| Up to 84 days |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |