NCT05347849已完成1 期
A Two-part Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal BPL-003 (5-Methoxy-N,N-dimethyltryptamine Benzoate) in Healthy Subjects
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
- 62
- 试验地点
- 1
- 主要终点
- Percentage of subjects with treatment emergent AEs (TEAES)
研究概览
简要总结
The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Part A only
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically healthy based on medical records and study specific assessments
排除标准
- •Presence or history of severe adverse reaction to any drug or drug excipient
研究组 & 干预措施
Placebo arm
Placebo Comparator
干预措施: Placebo (Other)
BPL-003 arm
Experimental
干预措施: BPL-003 (Drug)
结局指标
主要结局
Percentage of subjects with treatment emergent AEs (TEAES)
时间窗: From screening through to the follow up visit, up to 65 days
次要结局
- Peak plasma concentration (Cmax)(Day 1 (dosing day) and Day 2)
- Time to reach Cmax (tmax)(Day 1 (dosing day) and Day 2)
- Area under the plasma concentration- time curve(Day 1 (dosing day) and Day 2)
研究者
研究点 (1)
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