类似的药物动力学、安全性和耐受性的Etrolizumab由已经预装好的注射器或者自我注射器在随机试验中在健康志愿者。

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张W, Tyrrell H,叮HT,滑轮J, Boruvka,埃里克森R, Abouhossein M, Ravanello R,唐太

类似的药物动力学、安全性和耐受性的Etrolizumab由已经预装好的注射器或者自我注射器在随机试验中在健康志愿者。

阿你。2021年5月,38 (5):2418 - 2434。doi: 10.1007 / s12325 - 021 - 01661 - 6。Epub 2021年3月29日。

PubMed ID

33778929 (在PubMed

]

文摘

简介:Etrolizumab是一部小说,双重作用anti-beta7整合素抗体研究炎性肠道疾病患者的三期临床试验。一个自我注射器(AI)正在开发并行来补充肾上腺素注射器针安全装置(PFS-NSD)皮下(SC)政府在这些试验。这里我们展示类似的药物动力学、耐受性和安全的设备。方法:随机、非盲、两部分研究在健康参与者评价的可比性etrolizumab AI和PFS-NSD之间的接触。第1部分(试点)涉及少量的参与者,和最初的结果被用来定型(关键)第2部分更大的研究。在两个部分中,参与者被随机分配到接收单个SC剂量的人工智能或PFS-NSD etrolizumab 105毫克。随机化是由体重分层的。主要药代动力学结果Cmax、AUClast AUC0-inf。结果:一百八十名健康受试者(第1部分,n = 30;第2部分,n = 150)收到一个SC剂量的etrolizumab AI或PFS-NSD。 Primary pharmacokinetic results from part 1 supported modification of the part 2 study design. Results from part 2 demonstrated that etrolizumab exposure was equivalent between devices, with geometric mean ratios (GMRs) between AI and PFS-NSD of 102% (90% confidence interval [CI] 94.2-111) for Cmax, 98.0% (90% CI 89.3-107) for AUClast, and 97.6% (90% CI 88.6-107) for AUC0-inf. Median tmax and mean terminal t1/2 were also similar between devices. GMRs and 90% CIs of all primary pharmacokinetic parameters were fully contained within the predefined equivalence limits (80-125%). CONCLUSION: This pharmacokinetic study demonstrated that single SC injections of etrolizumab 105 mg using an AI or a PFS-NSD resulted in equivalent etrolizumab exposure and similar safety and tolerability in healthy participants. Taken together, these results support the use of an AI for etrolizumab administration. TRIAL REGISTRATION: NCT02996019.

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药物

Etrolizumab