首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >A novel recombinant soluble human thrombomodulin, ART-123, activates the protein C pathway in healthy male volunteers.
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A novel recombinant soluble human thrombomodulin, ART-123, activates the protein C pathway in healthy male volunteers.

机译:一种新型的重组可溶性人血栓调节蛋白ART-123激活了健康男性志愿者中的蛋白C途径。

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摘要

The effect of a novel recombinant soluble human thrombomodulin, ART-123, on protein C activation was investigated by measuring plasma prothrombinase activity in four healthy male volunteers. ART-123 at a dose of 0.3 mg was administered as a bolus intravenous injection for 1 minute. Plasma ART-123 concentration and prothrombinase activity were determined before and immediately, 24, and 48 hours after injection, and thromboelastography was recorded before and immediately and 24 hours after injection. The mean elimination half-life was 19.82 +/- 2.10 hours. Compared with pretreatment levels, ART-123 reduced prothrombinase activity by 44.2 +/- 11.7%, 52.1 +/- 10.8%, and 61.0 +/- 14.7%, respectively, immediately, 24, and 48 hours after injection, suggesting that ART-123 activated the protein C pathway. ART-123 did not affect thromboelastography values. There were no abnormal findings for objective signs or laboratory tests, including blood pressure, heart rate, electrocardiogram, body temperature, hematology, coagulation and hemostatic parameters, blood chemistry, and urinalysis. Based on these observations, ART-123 at a dose of 0.3 mg can activate the protein C pathway in healthy volunteers.
机译:通过测量四名健康男性志愿者的血浆凝血酶原活性,研究了新型重组可溶性人血栓调节蛋白ART-123对蛋白C活化的影响。以推注静脉内注射的形式以0.3mg的剂量施用ART-123 1分钟。在注射之前和之后,之后24和48小时测定血浆ART-123浓度和凝血酶原活性,并在注射之前和之后和24小时记录血栓弹性描记术。平均消除半衰期为19.82 +/- 2.10小时。与预处理水平相比,ART-123注射后立即,24和48小时分别降低了凝血酶原酶活性44.2 +/- 11.7%,52.1 +/- 10.8%和61.0 +/- 14.7%,这表明ART-123 123激活了蛋白C通路。 ART-123不会影响血栓弹性成像值。没有客观体征或实验室检查的异常发现,包括血压,心率,心电图,体温,血液学,凝血和止血参数,血液化学和尿液分析。基于这些观察结果,剂量为0.3 mg的ART-123可以激活健康志愿者中的C蛋白通路。

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