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目的:评价人CD11/CD18单克隆抗体(Hu23F2G)在多发性硬化病人中的安全性、药动学、药效学和致免疫性。 方法;在I期非对照逐步提高剂量的研究中,给患有1或2期多发件硬化的病人(n=24)单次注射Hu23F2G(0.001～4.0mg·kg(-1))。研究包括安全性、药理学、致免疫性和头部磁共振图像的参数。 结果:Hu23F2G几乎没有副作用,仅发生2例尿路感染和2例牙龈炎。接受剂量≥1.0mg·kg(-1)的病人,可出现短暂性白细胞上升。药动学数据是非线性的。由于增加剂量可见到药时曲线下面积增大,随剂量加大可使终末半衰期延长。在剂量为4.0mg·kg(-1)时,t_1/2为21.9h(标准差12.8)当使用剂量≥0.2mg·kg(-1)时,血循中白细胞的CD11/CD18可达到高度饱和(78％),其持续时间具有剂量依赖性,在
Objective: To evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of human CD11 / CD18 monoclonal antibody (Hu23F2G) in patients with multiple sclerosis. Methods; In a phase I uncontrolled dose escalation study, Hu23F2G (0.001-4.0 mg · kg -1) was given as a single injection to patients with one or more multiple sclerosis (n = 24). Studies include parameters for safety, pharmacology, immunogenicity, and head magnetic resonance imaging. Results: Hu23F2G had almost no side effects, only 2 urinary tract infections and 2 gingivitis. Patients receiving doses ≥1.0 mg · kg -1 may have transient leukocytosis. Pharmacokinetic data is non-linear. As the increase in dose can be seen when the medicine under the curve area increases, with the dose can increase the terminal half-life extension. At a dose of 4.0 mg · kg -1, t 1/2 was 21.9 h with a standard deviation of 12.8. The CD11 / CD18 of leukocytes in blood circulation reached a high degree of saturation when the dose was ≥ 0.2 mg · kg -1 (78%), the duration of which is dose dependent