An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics and Safety of GH001 Administered Via a GH001 Aerosol Delivery System in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)
研究概览
简要总结
The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) in the range of 18.5 to 35 kg/m2 (inclusive) at screening.
- •Good mental health in the opinion of the investigator.
- •Normal spirometry (FEV1 of >80% of predicted and FVC of >80% of predicted value) at screening.
排除标准
- •Has known allergies or hypersensitivity or any other contraindication to mebufotenin, bufotenin, melatonin or triptans.
- •Has received any investigational medication, including investigational vaccines, in the 90 days prior to baseline or is in the follow-up period of another clinical trial at the time of screening for this trial.
- •Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the investigator's judgement.
研究组 & 干预措施
GH001
A single inhaled dose of GH001 administered via a proprietary aerosol delivery device in 12 subjects
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
GH001
A single inhaled dose of GH001 administered via a proprietary aerosol delivery device in 12 subjects
干预措施: GH001 Aerosol Delivery System (Device)
结局指标
主要结局
Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)
时间窗: Day 1
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax)
时间窗: Day 1
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2)
时间窗: Day 1
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast)
时间窗: Day 1
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - Cmax/AUCinf
时间窗: Day 1
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Safety and tolerability: incidence of treatment-emergent adverse events
时间窗: Through trial completion, an average of 3 weeks
Incidence of adverse events reported in the study and coded by MedDRA.
Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUCinf)
时间窗: Day 1
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - Partial area under the curve between t1 and t2 (AUCt1-t2)
时间窗: Day 1
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - terminal elimination rate constant (λz)
时间窗: Day 1
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - apparent total body clearance (CL/F)
时间窗: Day 1
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - Apparent volume of distribution (up to bioavailability) following extravascular administration (Vz/F)
时间窗: Day 1
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
次要结局
未报告次要终点