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The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004 injection in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD, SHR-2004 | Experimental | Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 injection |
|
| SAD, SHR-2004 placebo | Placebo Comparator | Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 placebo injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAD, SHR-2004 | Drug | Ascending dose |
| |
| SAD, SHR-2004 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs) | up to day 113 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Drum Tower Hospital of Nanjing University Medical school | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39166425 | Derived | Ma T, Weng Z, Cao B, Dong Y, Deng C, Huang L, Yang Y, Wang Y, Shen C, Wang L, Shen K, Li J. The first-in-human study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the factor XI monoclonal antibody SHR-2004 in healthy subjects. Expert Opin Investig Drugs. 2024 Oct;33(10):1075-1082. doi: 10.1080/13543784.2024.2391837. Epub 2024 Aug 22. |
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SHR-2004 injection compared with placebo
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| Drug |
Ascending dose |
|
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D064346 | Sagittal Abdominal Diameter |
| ID | Term |
|---|---|
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |
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