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MBX2109,一种每周一次的甲状腺激素替代疗法原药:第一阶段,首次对人进行随机试验

Patricia Carney¹, Gordon B Cutler², Kristi Schneider³

¹Clinical Operations, MBX Biosciences Inc, Carmel, IN 46032, USA.

The Journal of clinical endocrinology and metabolism

|November 22, 2024

概括

一种新的副甲状腺激素 (PTH) 前药物MBX2109在健康志愿者中表现出良好的耐受性. 它的长半衰期支持一个方便的每周一次的剂量方案,用于潜在的PTH替代疗法.

科学领域:

内分泌学在内分泌学.
药理学药理学是指药理学的学科.

背景情况:

甲状腺功能低下症的特征是甲状腺类激素 (PTH) 缺乏,导致矿物代谢受损.
MBX 2109是一种新型前药,旨在用于长期作用,每周一次的PTH替代疗法.

研究的目的:

在健康志愿者中评估MBX 2109的安全性,药理动力学 (PK) 和药理动力学 (PD).

主要方法:

一个第一阶段,随机,双盲,安慰剂控制的研究,涉及多次上升剂量的MBX 2109,每周一次,每周一次,每周一次,每周一次,每周四次.
参与者被分配给接受MBX 2109 (200-900mcg) 或安慰剂,比例为4:1.

主要成果:

MBX 2109通常耐受良好,没有报告严重或严重的治疗出现不良事件 (TEAE).
注射部位反应是最常见的与治疗相关的TEAE.
活性PTH显示剂量和时间依赖的暴露,MBX 2109的半衰期为79-95小时,活性的半衰期为184-213小时.

结论:

作为一种持续作用的PTH前药物,MBX 2109表现出良好的安全性和耐受性,没有意外的非目标效应.
其活性PTH激动剂的长半衰期和一致的暴露档案支持每周一次的剂量计划.
确定了MBX 2109未来临床研究的剂量.

关键词:

激素替代疗法是一种激素替代疗法.过低血症 (hypocalcemia) 的情况甲状腺过敏症 (hypoparathyroidism) 是一种严重的疾病.甲状腺上腺激素激素的作用类治疗药物类治疗药物药物前体是药物前体.

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