NCT06702332已完成1 期
A Randomized, Double-blind, Placebo-controlled, Sequential, Adaptive Single Ascending Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamic Profile of Orally Administered MSD-001 in Healthy Participants.
Mindstate Design Labs1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2024年11月11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
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Assess the safety and tolerability of MSD-001 in healthy adult participants by assessing the number, duration, severity, drug relatedness and type of adverse events
研究概览
简要总结
The purpose of this Phase 1 single ascending dose (SAD) study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamic profile of MSD-001 when administered orally to healthy adult participants.
详细描述
This is a first in human, prospective, single center, double blind, placebo-controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MSD-001. The study will include two parallel parts, Part 1 and Part 2, stratified by CYP2D6 phenotype.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female healthy consented participants 18 to 55 years of age
- •CYP2D6 phenotype established based on pharmacogenetic testing.
- •Free from psychoactive drug use from 4 weeks before dosing and until the last follow up visit.
排除标准
- •Any current clinically relevant, or history of, acute or chronic diseases inclusive of psychiatric disorders and relevant family history, which could interfere with the participant's safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.
- •Moderate to severe congestive heart failure, history of heart surgery, pulmonary hypertension, systemic hypertension (i.e., systolic BP >139 mm hg, diastolic blood pressure > 89 mm hg), pulse rate > 90 bpm, clinically significant ECG abnormality, QTc > 450 msec, myocardial infarction in the past year, or any other active or severe cardiovascular condition.
- •Clinically significant personal or familial history of epilepsy, seizures, convulsions, or other seizure disorder (excluding febrile seizures as a child), previous head trauma or other risk factor for seizure.
- •Use of any psychedelic drug in the three months prior to planned dosing or the occurrence of persistent psychological effects following the previous use of psychedelic drugs.
- •Subject experiences severe anticipatory anxiety or is otherwise considered unfit for study.
- •History of moderate or severe illicit substance abuse or dependence, or a positive test result(s) for alcohol and/or drugs of abuse at screening or admission to the clinical unit.
- •Subject has received a prior investigational intervention, has had a history of relevant hypersensitivity or allergic reactions, and has donated and/or received any blood or blood products or experienced blood loss, that may interfere with the objectives of the study.
- •Subject has a significant negative life event (e.g. loss of a loved one) in the past 6 months.
研究组 & 干预措施
Active Treatment: MSD-001
Active Comparator
Planned doses of MSD-001; N = 42
干预措施: MSD-001 (Drug)
Placebo Comparator
Placebo Comparator
Non-active study drug N = 10
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Assess the safety and tolerability of MSD-001 in healthy adult participants by assessing the number, duration, severity, drug relatedness and type of adverse events
时间窗: up to 30 days
Treatment emergent adverse events/ treatment emergent serious adverse events - their frequency, duration and severity, clinically significant changes in lab parameters, ECG, and vital signs
次要结局
- Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Maximum Plasma Concentration (Cmax)(Pre-dose and up to 24 hours post dose)
- Plasma Pharmacokinetics (PK) of a single dose of MSD-001: time to attain Cmax (Tmax)(Pre-dose and up to 24 hours post dose)
- Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Area under plasma Concentration (AUC)(Pre-dose and up to 24 hours post dose)
- Plasma Pharmacokinetics (PK) of a single dose of MSD-001: terminal elimination half-life (T1/2)(Pre-dose and up to 24 hours post dose)
- 5D-ASC (5 dimensional altered states of consciousness) rating scale (a 94-item VAS questionnaire)(Pre-dose and 24 hours post dose)
研究者
研究点 (1)
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