A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Relative Bioavailability and Food Effect Cohort to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of CYB003 in Healthy Participants With and Without Major Depressive Disorder (MDD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 3
- 主要终点
- Resting 12 Lead ECG ventricular rate (Arms C & D)
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in healthy participants with and without major depressive disorder (MDD).
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A: MDD Participants - CYB003 in 2 of 2 Medicine Sessions
Arm A MDD participants will receive CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. The CYB003 dose received will depend on the cohort/time of enrollment. All MDD participants will receive supportive EMBARK psychotherapy throughout the study.
干预措施: CYB003 (Drug)
A: MDD Participants - CYB003 in 2 of 2 Medicine Sessions
Arm A MDD participants will receive CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. The CYB003 dose received will depend on the cohort/time of enrollment. All MDD participants will receive supportive EMBARK psychotherapy throughout the study.
干预措施: Psychotherapy (Behavioral)
B: MDD Participants - Placebo in Medicine Session 1, CYB003 in Medicine Session 2
Arm B MDD participants will receive placebo in Medicine Session 1, and approximately three weeks later will receive CYB003 in Medicine Session 2. The CYB003 dose received will depend on the cohort/time of enrollment. All MDD participants will receive supportive EMBARK psychotherapy throughout the study.
干预措施: CYB003 (Drug)
B: MDD Participants - Placebo in Medicine Session 1, CYB003 in Medicine Session 2
Arm B MDD participants will receive placebo in Medicine Session 1, and approximately three weeks later will receive CYB003 in Medicine Session 2. The CYB003 dose received will depend on the cohort/time of enrollment. All MDD participants will receive supportive EMBARK psychotherapy throughout the study.
干预措施: Psychotherapy (Behavioral)
B: MDD Participants - Placebo in Medicine Session 1, CYB003 in Medicine Session 2
Arm B MDD participants will receive placebo in Medicine Session 1, and approximately three weeks later will receive CYB003 in Medicine Session 2. The CYB003 dose received will depend on the cohort/time of enrollment. All MDD participants will receive supportive EMBARK psychotherapy throughout the study.
干预措施: Placebo (Drug)
C: Healthy Volunteers - CYB003 in 2 of 2 Medicine Sessions
Arm C healthy volunteers will receive CYB003 in 2 of 2 medicine sessions, approximately one to two weeks apart. The CYB003 dose received will depend on the cohort/time of enrollment. All healthy volunteers will receive psychological support throughout the study.
干预措施: CYB003 (Drug)
C: Healthy Volunteers - CYB003 in 2 of 2 Medicine Sessions
Arm C healthy volunteers will receive CYB003 in 2 of 2 medicine sessions, approximately one to two weeks apart. The CYB003 dose received will depend on the cohort/time of enrollment. All healthy volunteers will receive psychological support throughout the study.
干预措施: Psychological Support (Behavioral)
D: Healthy Volunteers - Placebo in Medicine Session 1, CYB003 in Medicine Session 2
Arm D healthy volunteers will receive placebo in Medicine Session 1, and approximately one to two weeks later will receive CYB003 in Medicine Session 2. The CYB003 dose received will depend on the cohort/time of enrollment. All healthy volunteers will receive psychological support throughout the study.
干预措施: CYB003 (Drug)
D: Healthy Volunteers - Placebo in Medicine Session 1, CYB003 in Medicine Session 2
Arm D healthy volunteers will receive placebo in Medicine Session 1, and approximately one to two weeks later will receive CYB003 in Medicine Session 2. The CYB003 dose received will depend on the cohort/time of enrollment. All healthy volunteers will receive psychological support throughout the study.
干预措施: Placebo (Drug)
D: Healthy Volunteers - Placebo in Medicine Session 1, CYB003 in Medicine Session 2
Arm D healthy volunteers will receive placebo in Medicine Session 1, and approximately one to two weeks later will receive CYB003 in Medicine Session 2. The CYB003 dose received will depend on the cohort/time of enrollment. All healthy volunteers will receive psychological support throughout the study.
干预措施: Psychological Support (Behavioral)
E: Healthy Volunteers - CYB003 in 3 of 3 Medicine Sessions
Arm E healthy volunteers will receive CYB003 in 3 of 3 medicine sessions, approximately one week apart from each other, to assess bioavailability and food effect. The CYB003 dose received will depend on the safety review committee selection/time of enrollment. All healthy volunteers will receive psychological support throughout the study.
干预措施: CYB003 (Drug)
E: Healthy Volunteers - CYB003 in 3 of 3 Medicine Sessions
Arm E healthy volunteers will receive CYB003 in 3 of 3 medicine sessions, approximately one week apart from each other, to assess bioavailability and food effect. The CYB003 dose received will depend on the safety review committee selection/time of enrollment. All healthy volunteers will receive psychological support throughout the study.
干预措施: Psychological Support (Behavioral)
结局指标
主要结局
Resting 12 Lead ECG ventricular rate (Arms C & D)
时间窗: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
ventricular rate (beats per minute)
Resting 12 Lead ECG ventricular rate (Arms E)
时间窗: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
ventricular rate (beats per minute)
Adverse Events (All Arms)
时间窗: Day 1 thru End of Study Visit (which is: Day 56 Arms A & B; Day 28 Arms C & D; Day 35 Arms E)
Any untoward medical occurrence in a clinical investigation participant administered a drug and does not necessarily have a causal relationship with the treatment
Resting 12 Lead ECG ventricular rate (Arms A & B)
时间窗: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, & Day 23
ventricular rate (beats per minute)
Resting 12 Lead ECG QTcF (Arms E)
时间窗: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Corrected QT interval by Fredericia (milliseconds)
Columbia Suicide Severity Rating Scale (CSSRS) Lifetime version (All Arms)
时间窗: Screening
Evaluation tool that evaluates a lifetime history of suicidal ideation and/or behavior. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care).
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arm E)
时间窗: Day -1, Day 2, Day 7, Day 9, Day 14, Day 16, Day 21, Day 28, Day 35
Evaluation tool that evaluates risk for suicide since the last study visit. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care).
Resting 12 Lead ECG PR interval (Arms A & B)
时间窗: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
PR interval (milliseconds)
Resting 12 Lead ECG PR interval (Arms C & D)
时间窗: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
PR interval (milliseconds)
Resting 12 Lead ECG PR interval (Arms E)
时间窗: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
PR interval (milliseconds)
Resting 12 Lead ECG QRS duration (Arms A & B)
时间窗: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
QRS duration (milliseconds)
Resting 12 Lead ECG QRS duration (Arms E)
时间窗: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
QRS duration (milliseconds)
Resting 12 Lead ECG QT interval (Arms A & B)
时间窗: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
QT interval (milliseconds)
Resting 12 Lead ECG QT interval (Arms C & D)
时间窗: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
QT interval (milliseconds)
Resting 12 Lead ECG QT interval (Arms E)
时间窗: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
QT interval (milliseconds)
Resting 12 Lead ECG QTcF (Arms A & B)
时间窗: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Corrected QT interval by Fredericia (milliseconds)
Resting 12 Lead ECG QTcF (Arms C & D)
时间窗: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Corrected QT interval by Fredericia (milliseconds)
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arms A & B)
时间窗: Day -1, Day 2, Day 10, Day 17, Day 21, Day 23, Day 31, Day 38, Day 42, and Day 56
Evaluation tool that evaluates risk for suicide since the last study visit. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care).
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arms C & D)
时间窗: Day -1, Day 2, Day 7, Day 9, Day 15, Day 21, Day 28
Evaluation tool that evaluates risk for suicide since the last study visit. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care).
Resting 12 Lead ECG QRS duration (Arms C & D)
时间窗: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
QRS duration (milliseconds)
Holter monitoring (Arms A & B)
时间窗: Day -1, Day 1, Day 22
Record of the electrical activity of the heart (Hz)
Holter monitoring (Arms C & D)
时间窗: Day -1, Day 1, Day 8
Record of the electrical activity of the heart (Hz)
Holter monitoring (Arm E)
时间窗: Day -1, Day 1, Day 8, Day 15
Record of the electrical activity of the heart (Hz)
次要结局
- Mystical Experience Questionnaire (MEQ30) (Arms C & D)(Day 1, Day 8, & Day 15)
- 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) (Arm E)(Day 1, Day 8, & Day 15)
- Hallucinogen Rating Scale (HRS) (Arms A & B)(Day 1 & Day 22)
- 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) (Arms C & D)(Day 1 & Day 8)
- Hallucinogen Rating Scale (HRS) (Arms C & D)(Day 1 & Day 8)
- Hallucinogen Rating Scale (HRS) (Arm E)(Day 1, Day 8, & Day 15)
- Mystical Experience Questionnaire (MEQ30) (Arms A & B)(Day 1 & Day 22)
- 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) (Arms A & B)(Day 1 & Day 22)
- VAS Ratings of "Any Drug Effect" (Arms A & B)(Day 1 & Day 22)
- Persisting Effects Questionnaire (PEQ) (Arms A & B)(Day 1 & Day 22)
- Persisting Effects Questionnaire (PEQ) (Arms C & D)(Day 1 & Day 8)
- Persisting Effects Questionnaire (PEQ) (Arm E)(Day 1, Day 8, & Day 15)
- VAS Ratings of "Any Drug Effect" (Arms C & D)(Day 1 & Day 8)
- VAS Ratings of "Any Drug Effect" (Arm E)(Day 1, Day 8, & Day 15)
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from screening (Arms A & B)(Screening, Day -1, Day 1, Day 10, Day 17, Day 31, & Day 38)
- Pharmacokinetic parameter of psilocin (Cmax) (Arms A & B)(Day 1, Day 2, Day 22, & Day 23)
- Pharmacokinetic parameter of psilocin (Cmax) (Arms C & D)(Day 1, Day 2, Day 8, & Day 9)
- Pharmacokinetic parameter of psilocin (Cmax) (Arm E)(Day 1, Day 2, Day 8, Day 9, Day 15, & Day 16)
- Pharmacokinetic parameter of psilocin (AUC) (Arms A & B)(Day 1, Day 2, Day 22, & Day 23)
- Pharmacokinetic parameter of psilocin (AUC) (Arms C & D)(Day 1, Day 2, Day 8, & Day 9)
- Pharmacokinetic parameter of psilocin (AUC) (Arm E)(Day 1, Day 2, Day 8, Day 9, Day 15, & Day 16)