A Phase I, Randomized, Double-blind, Placebo-controlled, 3-way Cross-over Study to Assess the Pharmacodynamic Effects of Two-dose Levels of QRL-101 on Transcranial Magnetic Stimulation and Nerve Excitability Threshold Tracking in Healthy Participants

QurAlis Corporation1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2024年10月7日最近更新: 2025年3月25日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: QurAlis Corporation
入组人数: 24
试验地点: 1
主要终点: Single pulse TMS-EMG motor evoked potential (MEP) amplitude (μV) compared to placebo

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

This is a phase I, prospective, single-center, randomized, double-blind, placebo-controlled, three-way cross-over study to evaluate the safety and tolerability of QRL-101 and investigate the pharmacodynamic effects of two dose levels of QRL-101 on transcranial magnetic stimulation (TMS) and nerve excitability threshold tracking (NETT) in healthy participants.

After screening and training, participants will be randomized to one of six treatment sequences of William's square balanced for first-order carry-over design consisting of two doses of QRL-101 or placebo, with at least seven days between each treatment.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Double (Participant, Investigator)

盲法说明

A participant and investigator-blinded, randomized, placebo-controlled design will be used to minimize bias in this study.

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Males and postmenopausal women between the ages ≥ 18 and ≤
•BMI ≥ 18.0 and ≤ 32.0 kg/m2, and body weight ≥ 50 kg, at screening.
•Willing and able to practice effective contraception from the screening through at least 2 days after their last dose of study treatment.
•Participants must be able to communicate effectively (in Dutch) with the study personnel and be willing to comply with the requirements of the study.

排除标准

•Evidence of any acute or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study.
•History or presence of conditions which, in the judgment of the investigator, are known to interfere with drug absorption, distribution, metabolism, or excretion.
•History or presence of conditions which might increase the risk of performing TMS (e.g., epilepsy, febrile seizures, intracranial mass lesion, hydrocephalus, clinically significant head injury or trauma, metal objects in the brain or skull, cochlear implant or a deep brain stimulation device)
•Any condition that could interfere with the quality of, or ability to perform, TMS (e.g., an abnormal sleeping pattern, unremovable dreadlocks or hairpieces, or a resting motor threshold (rMT) of more than 75%.
•*Other inclusion and exclusion criteria may apply*