A Phase 1 Translational Study to Assess Brain Activity Using Functional Magnetic Resonance Imaging (fMRI) and to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Functional magnetic resonance imaging (fMRI).
研究概览
简要总结
MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions.
The purpose of this trial is to investigate brain activity, safety, tolerability, and PK of multiple doses of MLS101 in healthy participants.
详细描述
In recent years, high-dose psilocybin has gained attention for it potential therapeutic benefit in many psychiatric conditions, however existing clinical data for low psilocybin doses are limited.
The multiple-dose regimen proposed in this study is designed to optimize the pharmacology of MLS101 and elucidate whether it provides a longer period of positive effects, which could be used in future studies in chronic indications such as PMDD, obsessive compulsive disorder and opioid use disorder. Translational functional magnetic resonance imaging (fMRI) imaging will confirm the central nervous system (CNS) activity of priming and repeat low-dose psilocybin, which will serve as a computational evaluation of efficacy and complement the cognitive and perceptual scales and questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 or females aged 18 to 55 years old (inclusive) at the time of signing the informed consent form.
- •Standard contraception measures are required for this clinical trial.
- •Healthy, in the opinion of the Investigator, based on prior (history of) or current (ongoing) medical and psychiatric screening assessments.
- •Participants with no clinically significant findings on physical examination, laboratory tests, and cardiac assessment.
- •Body mass index (BMI) within the range 18-32 kg/m2, inclusive.
- •Normal blood pressure.
- •Willing to not operate heavy machinery, including driving a vehicle at least 36 hours post Day 1 dose administration and 24 hours post all other dose administrations.
- •Capable of giving signed informed consent which includes the requirements and restrictions as per the approved study protocol
排除标准
- •Prior known exposure to psilocybin, LSD, ayahuasca, N, N-Dimethyltryptamine, and related tryptamines, within the past 5 years.
- •Prior (history of) or current (ongoing) diagnosis, or first-degree relatives with clinically significant medical or psychiatric condition or disease.
- •History of non-hospitalized but medicated Major Depressive Disorder (MDD), Generalized Anxiety Disorder or Panic Disorder ≤ 5 years prior to Screening.
- •History of or presence of cardiovascular disease.
- •Abnormal and clinically significant ECG.
- •Known personal or family history of congenital long QT syndrome or sudden death.
- •Current or a history of orthostatic hypotension or postural orthostatic tachycardic syndrome, multiple syncopes, or unresolved/ongoing clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness.
- •History or presence of a neurodegenerative disorder such Alzheimer's disease or Parkinson's disease or other behavioral disturbances resulting from other neurological disorders.
- •Use of medications that have CNS effects or affect performance.
- •Use of medications with serotonergic activity.
- •History or presence of hypersensitivity or idiosyncratic reaction to psilocybin or related compounds or microcrystalline cellulose
- •History of substance or alcohol abuse disorder in the last 10 years.
- •Participant who, for any reason, is deemed by the Investigator to be inappropriate for this study.
- •Contraindications to magnetic resonance imaging (MRI) or fMRI.
研究组 & 干预措施
MLS101
干预措施: Psilocybin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Functional magnetic resonance imaging (fMRI).
时间窗: Screening to Day 23
Global functional connectivity
Number and severity of treatment-emergent adverse events (TEAEs)
时间窗: Screening (Day -90) to end of study visit (Day 44)
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent adverse event (TEAE) if the onset date and time is at the time of or after first study drug administration.
次要结局
- Pharmacokinetics of MLS101: area under the plasma concentration-time curve (AUC)(Day 1 to Day 16)
- Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)(Day 1 to Day 16)
- Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (Tmax)(Day 1 to Day 16)
- Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F)(Day 1 to Day 16)
- Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F)(Day 1 to Day 16)
- Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½)(Day 1 to Day 16)