Phase 1 Randomised Clinical Trial of the First-in-Class KMO inhibitor KNS366
Phase 1 Randomised Clinical Trial of the First-in-Class KMO inhibitor KNS366
批准号:
10017279
负责人:
金额:
$324.53万
依托单位:
依托单位国家:
英国
项目类别:
Collaborative R&D
财政年份:
2022
资助国家:
英国
项目状态:
已结题
起止时间:
2022 至 --
中文摘要
我们公司Kynos Therapeutics有限公司正在开发一种新型药物,用于治疗由炎症引起的疾病,特别是大型心脏直视手术后的肾脏损伤,这种药物也可能用于治疗癌症。这种新药影响细胞和组织的代谢,特别是免疫系统细胞的功能。我们的新药具备成功治疗病人所需的所有特征,并已在实验模型中进行了广泛的安全测试。为了继续新药开发进程,我们现在需要确保这种新药对人类使用是安全的。这个项目是一个招募健康志愿者的临床试验,我们会仔细地测量新药的安全性,我们会给一个非常低的剂量,然后在不同的志愿者群体中逐渐增加剂量,最终达到我们预期的患者使用剂量水平。在整个过程中,志愿者的安全将是我们的首要任务。如果我们的项目成功,药物对人体是安全的,血液测试表明药物以我们预期的方式改变新陈代谢,我们将做出一个改变游戏规则的飞跃,并打开了涉及患者的后续临床试验的大门,最初是试验药物是否可以预防大型心脏手术后的肾脏损伤。
英文摘要
Our company, Kynos Therapeutics Ltd., is developing a new kind of medicine to treat diseases caused by inflammation, especially kidney damage after major open heart surgery, and that may also have a use against cancer. This new medicine affects the metabolism of cells and tissues, and especially how cells of the immune system function. Our new medicine has all the characteristics required to be developed into a successful drug for patients, and has been extensively safety-tested in experimental models.\r\rIn order to continue the new medicines development process, we need to now make sure that this new medicine is safe for human use. In this project, which is a clinical trial recruiting healthy volunteers, we will carefully measure the safety of the new medicine by giving a very low dose of the new medicine and gradually increasing the dose across different groups of volunteers, ultimately reaching a dose level that we expect will be the dose used in patients. Throughout all of this process, the safety of the volunteers will be our foremost priority.\r\rIf our project is successful and the medicine is safe in humans, and blood tests show that the medicine changes metabolism in the way we expect it to, we will have made a game-changing leap forward and opened the door to follow-on clinical trials involving patients, initially to trial whether the medicine can prevent kidney damage after major open heart surgery.
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