在喘患者中,SHR-1703是一种新型的长效抗列素-5单克隆抗体:一项随机,双盲,安慰剂控制的第一阶段研究
Ling Yang1, Lixiu He1, Yajun Zhang2
1Clinical Trial Center, West China Hospital of Sichuan University, Chengdu, China.
British journal of clinical pharmacology
|January 6, 2026
概括
SHR-1703,一种新型的抗素-5抗体,在患有酸性喘的患者中表现出良好的耐受性和显著的有效性,降低了酸蛋白. 这种治疗有望改善喘控制.
科学领域:
- 免疫学 免疫学 免疫学
- 肺部病理学 肺部病理学
- 药理学 药理学是指药理学的学科.
背景情况:
- 干白素5 (IL-5) 是一种关键的调解者,在与乙酸相关的疾病,如乙酸性喘.
- SHR-1703是一种针对IL-5的新型人性化单克隆抗体,旨在增强喘管理.
研究的目的:
- 评估SHR-1703在喘患者中的安全性,耐受性,药理动力学和药理动力学.
- 评估SHR-1703在降低乙氨基酸细胞数量的有效性.
主要方法:
- 一项单次上升剂量研究,涉及随机分配给SHR-1703 (400或600毫克) 或安慰剂的患者.
- 随访延长至第281天,安全性和耐受性作为主要终点.
主要成果:
- SHR-1703耐受性良好,治疗出现的轻度至中度不良事件与安慰剂相比较.
- 药理动力学显示延长了半衰期 (大约. 75天) 在两剂剂量.
- 观察到外周血液中异氨基细胞的快速和持续减少 (>50%在1天内减少,持续>100天).
结论:
- 在喘患者中,SHR-1703具有良好的安全性和耐受性.
- 这种药物通过显著降低乙氨基酸水平来证明有希望的疗效,这表明改善喘控制的潜力.
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