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皮下RE104的安全性,耐受性,药理动力学和药理动力学:双盲,随机,单次上升剂量,安慰剂控制的双盲,随机研究

Guy Ludbrook^1,2, Nathan Bryson³, Beatrix Taylor³

¹PARC Clinical Research, Royal Adelaide Hospital.

Journal of clinical psychopharmacology

|July 21, 2025

概括

新型前药RE104在健康成年人中表现出良好的安全性,产生类似于 псилоцибин但持续时间较短的迷幻效应. 对其治疗潜力的进一步研究是有必要的.

科学领域:

心理药理学心理药理学
临床药理学临床药理学
神经科学是一个神经科学.

背景情况:

RE104是一种4-基-N,N-二异烯三胺 (4-OH-DiPT) 的前药物,是一种合成迷幻药.
这项研究是首次对RE104的安全性,耐受性,药理动力学和药理动力学进行正式的人体评估.

研究的目的:

评估RE104单次皮下注射剂在健康成年人中的安全性和耐受性.
描述RE104及其活性代谢物4-OH-DiPT的药理动力学和药理动力学特征.
探索RE104剂量与主观迷幻体验之间的关系.

主要方法:

一个双盲,随机,安慰剂控制的第一阶段研究.
包括6个队伍,共计48名健康的成年参与者,有过以前的迷幻体验.
用RE104进行一次性皮下注射,剂量从5毫克到40毫克之间.

主要成果:

一般来说,RE104是安全的,并且可以很好地容忍高达40毫克的剂量,没有严重的不良事件.
药理动力学显示RE104暴露量与剂量成比例增加,并使4-OH-DiPT在血中迅速出现.
血中的4-OH-DiPT水平与药物效应和神秘体验的主观测量相关,在"完全神秘体验"反应者中,与剂量相关的增加.

结论:

单次皮下注射RE104产生了精神活性作用和有利的安全性,与西相似.
与传统迷幻药相比,RE104的精神活性效果持续时间较短 (3-4小时).
这些发现表明RE104的治疗应用潜力值得进一步研究.

关键词:

4替代的胺类药物.RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 RE104 确定剂量的方法.幻觉制造物幻觉制造物药物动力学药物动力学这种药物是psilocin.这种药物是psilocybin.迷幻类精神药物迷幻类精神药

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