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).
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Adverse Events (All Arms)
Timeframe: Day 1 thru End of Study Visit (which is: Day 56 Arms A & B; Day 28 Arms C & D; Day 35 Arms E)
Resting 12 Lead ECG ventricular rate (Arms A & B)
Timeframe: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, & Day 23
Resting 12 Lead ECG ventricular rate (Arms C & D)
Timeframe: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Resting 12 Lead ECG ventricular rate (Arms E)
Timeframe: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Resting 12 Lead ECG PR interval (Arms A & B)
Timeframe: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Resting 12 Lead ECG PR interval (Arms C & D)
Timeframe: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Resting 12 Lead ECG PR interval (Arms E)
Timeframe: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Resting 12 Lead ECG QRS duration (Arms A & B)
Timeframe: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Resting 12 Lead ECG QRS duration (Arms C & D)
Timeframe: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Resting 12 Lead ECG QRS duration (Arms E)
Timeframe: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Resting 12 Lead ECG QT interval (Arms A & B)
Timeframe: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Resting 12 Lead ECG QT interval (Arms C & D)
Timeframe: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Resting 12 Lead ECG QT interval (Arms E)
Timeframe: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Resting 12 Lead ECG QTcF (Arms A & B)
Timeframe: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Resting 12 Lead ECG QTcF (Arms C & D)
Timeframe: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Resting 12 Lead ECG QTcF (Arms E)
Timeframe: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Holter monitoring (Arms A & B)
Timeframe: Day -1, Day 1, Day 22
Holter monitoring (Arms C & D)
Timeframe: Day -1, Day 1, Day 8
Holter monitoring (Arm E)
Timeframe: Day -1, Day 1, Day 8, Day 15
Columbia Suicide Severity Rating Scale (CSSRS) Lifetime version (All Arms)
Timeframe: Screening
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arms A & B)
Timeframe: Day -1, Day 2, Day 10, Day 17, Day 21, Day 23, Day 31, Day 38, Day 42, and Day 56
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arms C & D)
Timeframe: Day -1, Day 2, Day 7, Day 9, Day 15, Day 21, Day 28
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arm E)
Timeframe: Day -1, Day 2, Day 7, Day 9, Day 14, Day 16, Day 21, Day 28, Day 35