单剂、安慰剂对照、随机研究AMG 785 sclerostin单克隆抗体。

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方Padhi D,张成泽G, Stouch B, L, Posvar E

单剂、安慰剂对照、随机研究AMG 785 sclerostin单克隆抗体。

J骨矿研究》2011年1月,26 (1):19-26。doi: 10.1002 / jbmr.173。

PubMed ID

20593411 (在PubMed

]

文摘

Sclerostin osteocyte-secreted蛋白质,负调节成骨细胞和抑制骨形成。在这种first-in-human研究,sclerostin单克隆抗体(AMG 785)是管理健康男性和绝经后妇女。在这个阶段,我随机、双盲、安慰剂对照,上升,单剂研究中,72名健康受试者收到AMG 785或安慰剂(3:1)皮下注射(0.1,0.3,1、3、5或10毫克/公斤)或静脉注射(1或5毫克/公斤)。根据剂量,受试者随访到85天。785 AMG的影响(主要目标)和药物动力学安全性和耐受性,骨代谢标志物,骨矿物质密度(二级目标)进行评估。AMG 785年一般耐受性良好。一个特异性的肝炎的治疗相关的严重不良事件报告并解决。没有死亡或研究中断发生。AMG 785药物动力学是非线性和剂量。剂量增加骨形成标志物胶原1型N-propeptide (P1NP),骨特异性碱性磷酸酶(BAP)和骨钙素的观察,随着剂量减少骨吸收标记血清C-telopeptide (sCTx),导致大量合成窗口。 In addition, statistically significant increases in bone mineral density of up to 5.3% at the lumbar spine and 2.8% at the total hip compared with placebo were observed on day 85. Six subjects in the higher-dose groups developed anti-AMG 785 antibodies, 2 of which were neutralizing, with no discernible effect on the pharmacokinetics or pharmacodynamics. In summary, single doses of AMG 785 generally were well tolerated, and the data support further clinical investigation of sclerostin inhibition as a potential therapeutic strategy for conditions that could benefit from increased bone formation.

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药物

Romosozumab