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临床试验/NCT06343636
NCT06343636已完成1 期

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VG-3927 in Healthy Adults

Vigil Neuroscience, Inc.3 个研究点 分布在 2 个国家目标入组 115 人开始时间: 2023年9月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
115
试验地点
3
主要终点
Adverse Events

研究概览

简要总结

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VG-3927 in Healthy Adults

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The participant is deemed healthy by the principal investigator, as determined by prestudy medical evaluation
  • The participant voluntarily agrees to participate in this study and signs an institutional review board approved informed consent

排除标准

  • The participant has any concurrent disease or condition that, in the opinion of the principal investigator, would make the participant unsuitable for participation in the clinical study

研究组 & 干预措施

Single and Multiple Ascending Dose

Experimental

Ascending single doses and multiple doses for healthy volunteers.

干预措施: VG-3927 (Drug)

Placebo

Placebo Comparator

Matching placebo

干预措施: Placebo (Drug)

Alzheimer's Disease

Experimental

Single Dose Open-label

干预措施: VG-3927 (Drug)

结局指标

主要结局

Adverse Events

时间窗: 28 days post last dose

To evaluate the safety and tolerability of VG-3927

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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