A Phase 1, First-in-human, Double-blind, Placebo-controlled, Randomized, Single- and Multiple-ascending-dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Administered by Intramuscular Injection in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of participants with Treatment Emergent Adverse Events as coded by MedDRA and assessed by CTCAE v4.0
研究概览
简要总结
The primary objective of the study is to assess the pharmacokinetics, safety, and tolerability of a single-dose and multiple-doses of 5-MeO-DMT administered by intramuscular (IM) injections in healthy subjects.
详细描述
This study is a phase 1, first-in-human, double-blind, placebo-controlled, randomized, single-dose and multiple-ascending-dose study of 5-MeO-DMT administered by intramuscular injection in 54 healthy subjects (adult male and/or females, 18-65 years of age). Subjects will be randomized 6:1 to receive 5-MeO-DMT or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Healthy adult male or female.
- •Aged at least 18 years but not older than 65 years, inclusive.
- •Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2, inclusive.
排除标准
- •History of significant hypersensitivity to the IP or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, or endocrine disorders, as determined by the investigator (or designee).
- •Participants who, in the opinion of the investigator (or designee), should not participate in this study.
- •Participant is participating in another study with a medical device or IP within the last 30 days prior to first study drug administration.
研究组 & 干预措施
Cohort 1 - 0.5 mg single-dose
A single 0.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
干预措施: 5-methoxy-N,N-dimethyltryptamine succinate salt (Drug)
Cohort 1 - 0.5 mg single-dose
A single 0.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
干预措施: Placebo (Drug)
Cohort 2 - 2.5 mg single-dose
A single 2.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
干预措施: 5-methoxy-N,N-dimethyltryptamine succinate salt (Drug)
Cohort 2 - 2.5 mg single-dose
A single 2.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
干预措施: Placebo (Drug)
Cohort 3 - 4.5 mg single-dose
A single 4.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
干预措施: 5-methoxy-N,N-dimethyltryptamine succinate salt (Drug)
Cohort 3 - 4.5 mg single-dose
A single 4.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
干预措施: Placebo (Drug)
Cohort 4 - 7 mg single-dose
A single 7 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
干预措施: 5-methoxy-N,N-dimethyltryptamine succinate salt (Drug)
Cohort 4 - 7 mg single-dose
A single 7 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
干预措施: Placebo (Drug)
Cohort 5 - 10 mg single-dose
A single 10 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
干预措施: 5-methoxy-N,N-dimethyltryptamine succinate salt (Drug)
Cohort 5 - 10 mg single-dose
A single 10 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
干预措施: Placebo (Drug)
Cohort 6 - 13 mg single-dose
A single 5-MeO-DMT 13 mg or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
干预措施: 5-methoxy-N,N-dimethyltryptamine succinate salt (Drug)
Cohort 8 - multiple-dose, 3 hour interval
Administration of up to two 5-MeO-DMT (2.5 mg followed by 7 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).
干预措施: 5-methoxy-N,N-dimethyltryptamine succinate salt (Drug)
Cohort 6 - 13 mg single-dose
A single 5-MeO-DMT 13 mg or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
干预措施: Placebo (Drug)
Cohort 7 - multiple-dose, 3 hour interval
Administration of up to two 5-MeO-DMT (2.5 mg followed by 4.5 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).
干预措施: 5-methoxy-N,N-dimethyltryptamine succinate salt (Drug)
Cohort 7 - multiple-dose, 3 hour interval
Administration of up to two 5-MeO-DMT (2.5 mg followed by 4.5 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).
干预措施: Placebo (Drug)
Cohort 8 - multiple-dose, 3 hour interval
Administration of up to two 5-MeO-DMT (2.5 mg followed by 7 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).
干预措施: Placebo (Drug)
Cohort 9 - multiple-dose, 3 hour interval
Administration of up to two 5-MeO-DMT (2.5 mg followed by 10.5 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).
干预措施: 5-methoxy-N,N-dimethyltryptamine succinate salt (Drug)
Cohort 9 - multiple-dose, 3 hour interval
Administration of up to two 5-MeO-DMT (2.5 mg followed by 10.5 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with Treatment Emergent Adverse Events as coded by MedDRA and assessed by CTCAE v4.0
时间窗: Up to 30 Days
Number of participants with TEAEs following administration of 5-MeO-DMT.
次要结局
- Plasma pharmacokinetic parameters of 5-MeO-DMT and bufotenine following a single-dose and multiple-doses of 5-MeO-DMT(Up to 24 hours)
- Urine pharmacokinetic parameters of 5-MeO-DMT and bufotenine following a single-dose and multiple-doses of 5-MeO-DMT(Up to 24 hours)