一个阶段我研究评估注入速度对疼痛的影响,耐受性,药物动力学在大容量皮下Gantenerumab管理健康的志愿者。

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Portron,约旦P, Draper K, Muenzer C, D迪克森,van Iersel T,霍夫曼C

一个阶段我研究评估注入速度对疼痛的影响,耐受性,药物动力学在大容量皮下Gantenerumab管理健康的志愿者。

其他。2020年1月,42 (1):108 - 120. - e1。doi: 10.1016 / j.clinthera.2019.11.015。Epub 2019年12月26日。

PubMed ID
31883703 (在PubMed
]
文摘

目的:Gantenerumab,一个完整的人anti-amyloid-beta IgG1单克隆抗体结合β-淀粉样蛋白聚集形式,正在调查作为一个潜在的疾病修饰治疗早期(有前驱症状的轻度)阿尔茨海默病(AD)。我们的研究比较了痛苦与5 - 15秒gantenerumab皮下注射和皮下gantenerumab的耐受性和药代动力学特性评估。方法:这个随机、非盲、single-active-dose安慰剂对照交叉研究是在50名健康的志愿者进行40 - 80岁没有临床重大疾病史,药物或酒精滥用,家族的历史早发性广告,或之前gantenerumab曝光。合格的参与者被随机分配到一个序列的300毫克SC gantenerumab注入腹部和2 SC安慰剂注射(1到腹部和1到大腿)在5到15秒。所有注射管理至少90分钟。参与者被评估为局部疼痛视觉模拟量表(血管)和口头评定量表;安全资料评估通过记录不良事件(AEs)和血浆药代动力学特性也被评估。发现:皮下gantenerumab注入后,疼痛脉管分数高出数值没有达到统计学意义的5 s和15秒注射组(脉管最小二乘均值差异,7.492毫米;95%置信区间,-4.439 - -19.423毫米)。在注射速度组,代表痛苦脉管得分相当后皮下gantenerumab和安慰剂注射进入腹部。 Pain was reported after needle insertion and immediately after dosing, subsiding within 5 min after the dose. The pain VAS score was numerically higher after SC placebo injection into the thigh versus abdomen (5-s injection group: mean [SD] VAS score, 26.68 [27.83] vs 19.20 [25.60] mm; 15-s injection group: mean [SD] VAS score, 14.16 [20.62] vs 9.48 [12.04] mm). No serious AEs were reported; no participants withdrew because of an AE. All AEs were of mild intensity, were transient, and had resolved without sequelae at follow-up. The most common AEs were injection site reactions; redness was the most frequently observed skin reactivity event after subcutaneous gantenerumab administration (5-s injection group: 36%; 15-s injection group: 32%). After subcutaneous administration, gantenerumab reached a peak plasma concentration at a median time of 119 h (approximately 5 days); plasma concentrations declined in a monoexponential manner. Comparable pharmacokinetic profiles were observed between the injection speed groups. IMPLICATIONS: Subcutaneous gantenerumab injections at speeds of 5 and 15 s were well tolerated in healthy volunteers and could enable at-home administration by patients with AD or their caregivers. ClinicalTrials.gov identifier: NCT02882009.

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