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This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to evaluate the Pharmacokinetics and safety of Telitacicept Pre-filled Injection and Freeze-dried powder Injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telitacicept Pre-filled Injection 80mg | Experimental |
| |
| Telitacicept Freeze-dried powder Injection 80mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telitacicept Pre-filled Injection 80mg | Drug | The patient received one treatment of Telitacicept 80mg in the test group |
|
| Measure | Description | Time Frame |
|---|---|---|
| C-max | Maximum observed plasma concentration | Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57 |
| AUC0-∞ | Area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration | Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| T-max | Time to reach maximum observed plasma concentration | Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57 |
| Evaluation of AEs (adverse events) | Through observing number of total AEs and number of subjects with AEs and other factors of AEs #to evaluate the safety and tolerance of healthy subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Binghua Xiao | Contact | 86-010-58076833 | binghua.xiao@remegen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | 550004 | China |
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| Telitacicept Freeze-dried powder Injection 80mg | Drug | The patient received one treatment of Telitacicept 80mg in the test group |
|
| Up to Day 57 |
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Tianjin People's Hospital | Recruiting | Tianjin | Tianjin Municipality | 300191 | China |
|