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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLX05 | Experimental |
| |
| US-sourced Erbitux® | Active Comparator |
| |
| CN-sourced Erbitux® | Active Comparator |
| |
| EU-sourced Erbitux® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX05 | Drug | A single dose of 250 mg/m2 HLX05 will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf) | up to 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum serum concentration | up to 29 days |
| Tmax | Time to reach maximum serum concentration | up to 29 days |
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Inclusion Criteria:
Subjects who meet all the following criteria are allowed to be enrolled:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu | Xuzhou | Jiangsu | China | |||
| Affiliated Hospital of Xuzhou Medical University |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| EU-Erbitux® | Drug | A single dose of 250 mg/m2 EU-Erbitux® injection will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion. |
|
| US-Erbitux® | Drug | A single dose of 250 mg/m2 US-Erbitux® injection will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion. |
|
| CN-Erbitux® | Drug | A single dose of 250 mg/m2 US-Erbitux® injection will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion. |
|
| CL | Total clearance | up to 29 days |
| λz | Apparent terminal elimination rate constant | up to 29 days |
| Jiangsu |
| Xuzhou |
| China |