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The purpose of this study is to evaluate the pharmacokinetic similarity of sintilimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process,also to determine Pharmacodynamics of sintilimab with different manufacturing process in 12 healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sintilimab (after the change) | Experimental |
| |
| sintilimab (before the change) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sintilimab (after the change) | Drug | 0.3mg/kg,I.V.,single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-experiment: Treatment-emergent Adverse Events (TEAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) incidence. | Day 43 | |
| Pre-experiment: Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) incidence. | Day 43 | |
| Formal test: Bioequivalence results using the area under the plasma concentration-time curve (AUC0-inf) as the judging indicators. | Day 57 | |
| Bioequivalence results using the peak serum drug concentration (Cmax) as the judging indicators. | Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Other PK parameters: Area under the plasma concentration-time curve (AUClast) | Day 57 | |
| Other PK parameters: Volume of distribution (V) | Day 57 | |
| Other PK parameters: Clearance (CL) . |
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Inclusion Criteria:
Exclusion Criteria:
Age≥18 years and ≤45 years, healthy male subjects
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Changsha | Hunan | 410006 | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| sintilimab (before the change) |
| Drug |
0.3mg/kg,I.V.,single dose |
|
| Day 57 |
| Other PK parameters: Half-life (t1/2). Other PK parameters, including but not limited to elimination half-life (t1/2). | Day 57 |
| The occurrence of Neutralizing antibodies Antibody(NAb) | Day 57 |
| The occurrence of Anti-drug Antibody(ADA) | Day 57 |
| PD indicator: PD-1 receptor occupancy rate. | Day 57 |