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This is a randomised, double-blind, positive drug parallel controlled clinical trial in China. In the trial, it is planned to enroll 88 subjects, randomized to two treatment groups in a ratio of 1:1 to receive the test drug and the positive control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIBP-04 | Experimental |
| |
| Bevacizumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIBP-04 | Drug | 3mg/kg, infusion in 90 minutes |
| |
| Bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Area under the concentration time curve of the analyte in serum over the time interval from 0 to the last measurable concentration at time "t" | From 0 to day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum measured concentration of the analyte in serum | From 0 to day 71 |
| AUCinf | Area under the concentration time curve of the analyte in serum over the time interval from 0 to extrapolated to infinite time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shanghai Institute Of Biological Products Co., Ltd | SINOPHARM | Study Director |
| The First Affiliated Hospital | Bengbu Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | China |
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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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| Drug |
3mg/kg, infusion in 90 minutes |
|
| From 0 to day 71 |
| Tmax | Time from dosing to maximum measured concentration | From 0 to day 71 |
| t1/2 | Terminal half life of the analyte in serum | From 0 to day 71 |
| λz | Terminal elimination rate constant | From 0 to day 71 |
| CL | Total clearance of the analyte in serum following IV infusion | From 0 to day 71 |
| Vd | Volume of distribution during the terminal phase λz following an intravascular dose | From 0 to day 71 |
| Immunogenicity | Incidence of anti drug antibodies (ADAs) and neutralizing anti drug antibodies(NAb) | From 0 to day 71 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |