Phase 1 Randomised Clinical Trial of the First-in-Class KMO inhibitor KNS366

首创KMO抑制剂KNS366的1期随机临床试验

• 批准号: 10017279
• 金额: $ 324.53万
• 依托单位: KYNOS THERAPEUTICS LTD
• 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
• 起止时间: 2022 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10017279
• 关键词: Phase; Randomised; Clinical; Trial; First

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.

我们公司Kynos Therapeutics Ltd.正在开发一种新的药物，用于治疗炎症引起的疾病，特别是心脏直视手术后的肾损伤，也可能用于抗癌。这种新药影响细胞和组织的新陈代谢，特别是免疫系统细胞的功能。我们的新药具有开发成为成功的患者药物所需的所有特征，并已在实验模型中进行了广泛的安全性测试。r\r为了继续新药开发过程，我们现在需要确保这种新药对人类使用是安全的。在该项目中，这是一项招募健康志愿者的临床试验，我们将通过给予非常低剂量的新药并在不同志愿者组中逐渐增加剂量来仔细测量新药的安全性，最终达到我们预期将用于患者的剂量水平。在整个过程中，志愿者的安全将是我们的首要任务。r\r如果我们的项目成功，药物在人体内是安全的，血液测试显示药物以我们预期的方式改变新陈代谢，我们将取得一个改变游戏规则的飞跃，并为涉及患者的后续临床试验打开大门，最初是为了试验药物是否可以预防心脏直视手术后的肾损伤。