克里斯普尔-卡斯治疗SNIPR001的安全性,恢复性和药学动力学:一阶段,随机化,双盲,首次在人体上,剂量升级研究
Anders Østergaard Petersen1, Birgitte Damholt1, Mette Grove1
1SNIPR Biome, Copenhagen, Denmark.
The Lancet. Microbe
|March 5, 2026
概括
一种菌体疗法SNIPR001在健康个体中证明了安全性和耐受性. 这种治疗针对大肠杆菌 (大肠杆菌) 而不会破坏肠道微生物群,支持进一步的临床试验.
科学领域:
- 微生物学与传染病的研究
- 遗传学和基因组学 遗传学和基因组学
- 药理学和毒理学 药理学和毒理学
背景情况:
- 接受干细胞移植的患者面临来自诸如大肠杆菌 (E. coli) 等多药耐药肠道病原体的血液感染风险.
- SNIPR001是一种新型的菌体尾酒,向肠道中的大肠杆菌殖民,节省有益的共生细菌.
- 这项研究旨在评估SNIPR001在健康人类参与者的安全性和耐受性.
研究的目的:
- 在健康志愿者中评估SNIPR001的安全性和耐受性.
- 为了研究SNIPR001.1.的药理动力学和药理动力学.
- 评估SNIPR001对肠道大肠杆菌水平和微生物组合的影响.
主要方法:
- 进行了一项随机的,安慰剂控制的,双盲的,首次在人体上进行的剂量升级试验.
- 健康的参与者每天两次接受SNIPR001 (10^8,10^10,或10^12 PFU) 或安慰剂的口服剂量,持续7天.
- 安全结果包括不良事件,而次要结果涉及SNIPR001恢复,大肠杆菌水平和微生物组分析.
主要成果:
- 仅报告了轻度至中度的不良事件,SNIPR001和安慰剂组之间没有显著差异.
- 主要在便样本中检测到SNIPR001,在血或尿液中的存在很小,在6个月后无法检测到.
- 虽然在最高剂量下观察到大肠杆菌水平的降低,但它没有达到统计学意义;微生物组组成基本上没有受到影响.
结论:
- 在健康的参与者中,SNIPR001被发现是安全的,并且能很好地耐受,仅限于胃肠道.
- 治疗没有导致肠道微生物组的系统性破坏.
- 这些发现支持SNIPR001在潜在的治疗应用中继续进行临床开发.
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