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This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the secondary objective is to evaluate its pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-2004 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2004 injection | Drug | dose 1 or dose 2 or dose 3 or dose 4 or dose 5 or dose 6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (including bleeding events) | Up to 136 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax) | Up to 136 Days | |
| Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC) | Up to 136 Days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Qi, M.D | Contact | 0518-82342973 | sheng.qi@hengrui.com |
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| Pharmacokinetics of Dupilumab: Elimination half life (t1/2) |
| Up to 136 Days |
| PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity | Up to 136 Days |
| PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT) | Up to 136 Days |
| Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004 | Up to 136 Days |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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