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This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) | Experimental |
| |
| Perjeta ® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) | Drug | A single intravenous infusion of HS627 420mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC)0-∞ | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ | 150 days |
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 150 days |
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 150 days |
| Measure | Description | Time Frame |
|---|---|---|
| The total clearance(CL) | Evaluation of the total clearance(CL) | 150 days |
| elimination half-life time(T1/2) | Evaluation of elimination half-life time(T1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I Clinical Research Center | Qingdao | Shandong | 266003 | China |
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| Perjeta ® | Drug | A single intravenous infusion of Perjeta ®420mg |
|
| 150 days |
| ID | Term |
|---|---|
| C485206 | pertuzumab |
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