NCT07604558进行中（未招募）1 期
An Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of Bretisilocin in Healthy Adult Japanese, Han Chinese, and Non-Asian Volunteers
AbbVie2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2026年5月26日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
- 试验地点
- 2
研究概览
简要总结
This study will assess the adverse events, tolerability, and how bretisilocin intramuscular (IM) Injection moves through the body of healthy adult Japanese, Han Chinese, and Non-Asian volunteers participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: Healthy adult Japanese male or female;
- •Japanese participants must be first-generation Japanese of full Japanese parentage residing outside of Japan for less than 5 years.
- •Group 2: Healthy adult Han Chinese male or female
- •Han Chinese participants must be first-generation Han Chinese of full Chinese parentage residing outside of China for less than 5 years.
- •Group 3: Healthy adult male or female volunteers of African, European, or Latin American descent.
- •A condition of general good health, based upon the results of a medical history, physical and neurological examination, vital signs, laboratory profile and 12-lead ECG.
排除标准
- •Current diagnosis or history of any clinically significant mental health disorder, cardiovascular disorder, metabolic disorder, or other disorder requiring pharmacologic or other medical treatment. (Previous psychological support without a diagnosed history of a mental health disorder would not be considered exclusionary.)
- •Clinically significant personal or familial history (first degree relative) of epilepsy, seizures, convulsions, or other seizure disorder (excluding febrile seizures as a child), previous head trauma or other risk factor for seizure (e.g., electrolyte disturbances, or structural neurological disorders).
- •Any use of psychoactive substances (including ketamine, esketamine, MDMA, cannabinoids, or nitrous oxide) during the 6 weeks prior to confinement.
研究组 & 干预措施
Group 1-Bretisilocin-Japanese
Experimental
Participants will receive bretisilocin intramuscular (IM) injection on day 1.
干预措施: Bretisilocin (Drug)
Group 1-Bretisilocin-Han Chinese
Experimental
Participants will receive bretisilocin intramuscular (IM) injection on day 1.
干预措施: Bretisilocin (Drug)
Group 1-Bretisilocin-Non-Asian
Experimental
Participants will receive bretisilocin intramuscular (IM) injection on day 1.
干预措施: Bretisilocin (Drug)
研究者
研究点 (2)
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