候选抗疟疾化合物MMV367的首次在人体上的安全性,耐受性,药理动力学和试点食品效应研究
Andrea Kuemmerle1, Nand Singh2, Denis Gossen3
1MMV Medicines for Malaria Venture, Geneva, Switzerland.
British journal of clinical pharmacology
|February 17, 2025
概括
新型抗疟疾药物MMV367在健康参与者中显示出良好的安全性和耐受性. 它的药理动力学特征支持疟疾治疗的进一步发展.
科学领域:
- 药理学和热带医学 热带医学
- 药物开发 药物开发
- 临床试验 临床试验
背景情况:
- 疟疾仍然是一个重大的全球卫生挑战,需要开发新的抗疟疾药物.
- MMV367是一种新型化合物,向Plasmodium falciparum乙烯共酶A合成酶10/11,这是寄生虫生存的关键酶.
研究的目的:
- 评估口服MMV367的安全性,耐受性和药理动力学在健康人体中.
- 为了确定MMV367的初始安全性和药理动力学概况,在首次对人类进行研究.
主要方法:
- 一项随机,双盲,安慰剂控制,单次上升剂量研究 (第1部分和第3部分) 在健康参与者中.
- 一项试点食品效应研究,评估MMV367在食和禁食条件下的生物可用性 (第二部分).
- 随后的队列接受了MMV367的剂量从100毫克到1500毫克,并对安全性和药理动力学参数进行监测.
主要成果:
- 总体而言,MMV367耐受性良好,治疗引起的不良事件发生率低 (36.8%与安慰剂44.4%相比).
- 没有观察到严重的不良事件或临床显著的生命体征,心电图或实验室测试的变化.
- 药物动力学分析显示,与食物一起服用时,剂量相称性,半衰期为16.5-18.4小时,生物可用性增加.
结论:
- 在健康参与者中,MMV367表现出可接受的安全性和耐受性.
- MMV367的药理动力学特征支持其作为潜在的抗疟疾药物的持续发展.
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