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Sponsor's R&D Strategy adjusted
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The purpose of this study is to assess the bioequivalence of SHR-1210 before and after process changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-test: ARM A | Experimental | SHR-1210 before process changes 20 mg |
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| Pre-test: ARM B | Experimental | SHR-1210 after process changes 20 mg |
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| Formal Test: ARM A | Experimental | SHR-1210 before process changes 20 mg |
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| Formal Test: ARM B | Experimental | SHR-1210 after process changes 20 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | Subjects will receive treatment SHR-1210 before process changes 20 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Pre-test: Incidence and severity of AE/SAE/AESI (rated based on CTCAE v5.0) | Day-1 to Day 46 | |
| Formal Test: Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: AUC0-inf | Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9 | |
| Formal Test: Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: the geometric mean ration | Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9 | |
| Formal Test: Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: 90% confidence interval (90% CI) of AUC0-inf | Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-test: Inter-individual coefficient of variation (CV) of the AUC0-inf of SHR-1210 | Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9 | |
| Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410023 | China |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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This study is divided into two parts: pre-test and formal test. Each experiment will have two independent cohorts of subjects who will receive the treatment(SHR-1210 before process changes and SHR-1210 after process changes,respectively), and each cohort will be followed by 192 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability.
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| SHR-1210 | Drug | Subjects will receive treatment SHR-1210 after process changes 20 mg |
|
| Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9 |
| Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: AUC0-t | Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9 |
| Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: Tmax | Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9 |
| Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: t1/2 | Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9 |
| Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: CL | Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9 |
| Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: Vss | Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9 |
| Formal Test: The incidence of anti-drug antibody (ADA) and neutralizing antibody (Nab) for SHR-1210 | Based on sampling times pre-dose on Day1, post-dose on Day 9 and Day 16 |
| Formal Test: Incidence and severity of adverse events (rated based on CTCAE 5.0) | Day-1, Day 1 to Day 46±7 |