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In this 94 healthy subjects Phase I clinical trial, we assess the clinical profile of Anfibatide, a specific glycoprotein Ib antagonist. This study represents the first clinical evidence that Anfibatide exhibits strong anti-platelet effects, excellent reversibility, and low bleeding potential in healthy human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose gourp 1 | Experimental | Anfibatide injection at the concentration of 0.33μg/60kg in healthy volunteers |
|
| Single dose group 2 | Experimental | Anfibatide injection at the concentration of 0.66μg/60kg in healthy volunteers |
|
| Single dose groups 3 | Experimental | Anfibatide injection at the concentration of1.0μg/60kg in healthy volunteers |
|
| Single dose group 4 | Experimental | Anfibatide injection at the concentration of 1.5μg/60kg in healthy volunteers |
|
| Single dose group 5 | Experimental | Anfibatide injection at the concentration of 2.0μg/60kg in healthy volunteers |
|
| Single dose group 6 | Experimental | Anfibatide injection at the concentration of 3.0μg/60kg in healthy volunteers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anfibatide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints | To investigate the number of adverse events in patients with single or multiple intravenous injection/infusion of Antiplatelet | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) | To observe area under curve characteristics of Anfibatide in single or multiple dose groups | Predose, 0,1,2,3,4,6,8,12,24,48,72,96 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34083615 | Derived | Li BX, Dai X, Xu XR, Adili R, Neves MAD, Lei X, Shen C, Zhu G, Wang Y, Zhou H, Hou Y, Ni T, Pasman Y, Yang Z, Qian F, Zhao Y, Gao Y, Liu J, Teng M, Marshall AH, Cerenzia EG, Li ML, Ni H. In vitro assessment and phase I randomized clinical trial of anfibatide a snake venom derived anti-thrombotic agent targeting human platelet GPIbalpha. Sci Rep. 2021 Jun 3;11(1):11663. doi: 10.1038/s41598-021-91165-8. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000592236 | agkisacucetin protein, Agkistrodon acutus |
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|
| Single dose group 7 | Experimental | Anfibatide injection at the concentration of 4.0μg/60kg in healthy volunteers |
|
| Single dose group 8 | Experimental | Anfibatide injection at the concentration of 5.0μg/60kg in healthy volunteers |
|
| Multiple dose group 9 | Experimental | Give intravenous injection of 3μg as the first dose and after 1.5 hours, infusion of the study product 0.12μg/h for 24 hours |
|
| Multiple dose group 10 | Experimental | Give intravenous injection of 3μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours. |
|
| Multiple dose group 11 | Experimental | Give intravenous injection of 5μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours |
|
|
| D006474 |
| Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |