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The purpose of this study is to evaluate the pharmacokinetic similarity, safety, and immunogenicity of Envafolimab in healthy male subjects before and after the manufacturing process change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Envafolimab with new manufacturing process | Experimental | 80 healthy male subjects with Envafolimab with new manufacturing process |
|
| Envafolimab with old manufacturing process | Active Comparator | 80 healthy male subjects with Envafolimab with old manufacturing process |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envafolimab with new manufacturing process | Drug | Dosage form: Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab. Treatment method: Envafolimab, single dose, 1 mg/kg, subcutaneously. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Area under the plasma concentration-time curve | From pre-dose to day 85 |
| Cmax | concentration | From pre-dose to day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-infinity | Area under the plasma concentration-time curve | From pre-dose to day 85 |
| Tmax | Time to maximum concentration | From pre-dose to day 85 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing He | Beijing Goboard Boren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Gaobo Boren Hosipital | Beijing | Beijing Municipality | 100070 | China |
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| ID | Term |
|---|---|
| C000718749 | envafolimab |
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|
| Envafolimab with old manufacturing process | Drug | Dosage form: Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab. Treatment method: Envafolimab, single dose, 1 mg/kg, subcutaneously. |
|
| CL | Clearance | From pre-dose to day 85 |
| λz | Apparent terminal elimination rate constant | From pre-dose to day 85 |
| t1/2 | Half-life ( | From pre-dose to day 85 |
| Vd | Volume of distribution | From pre-dose to day 85 |
| Safety and tolerance | Adverse events (AE) | From pre-dose to day 85 |
| Immunogenicity assessment | Anti-drug Antibody (ADA) | From pre-dose to day 85 |