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This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects. This study is divided into two parts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLX05 | Experimental |
| |
| EU-sourced Erbitux | Active Comparator |
| |
| US-sourced Erbitux | Active Comparator |
| |
| CN-sourced Erbitux | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant anti-EGFR human/murine chimeric monoclonal antibody injection | Drug | a single dose,250 mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf | Area under the serum concentration-time curve from time 0 to infinity | 0 to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum serum concentration | 0 to Day 29 |
| Tmax | Time to reach maximum serum concentration | 0 to Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | China |
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| CL | Total clearance | 0 to Day 29 |
| λz | Apparent terminal elimination rate constant | 0 to Day 29 |