CompletedPhase 1/2

A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder

United States57 participantsStarted 2022-08-02

Plain-language summary

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).

Who can participate

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria - MDD \& Healthy Volunteer Participants: * Aged between 21 to 65 years, inclusive, at Screening. * Has a BMI of 18 to 30 kg/m2, inclusive, at Screening. * Is ≥60 kg. * Is negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at Screening and at Day -1. * Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Additional Inclusion Criteria - MDD Participants Only: * Has a diagnosis of MDD (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \[DSM-V\] of moderate to severe degree), established through a full psychiatric work up, who are otherwise healthy. * Has been on a stable dose of antidepressant medication (no more than 50% change) in the last month prior to Screening and has had an inadequate response, as judged by the Investigator. Exclusion Criteria - MDD \& Healthy Volunteer Participants: * Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview. * Clinically relevant history of abnormal physical health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including \[but not limited to\], neurological, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder). * Diagnosis of hypertension or an arrhythmia. * History of hypothyroidism and/or curr…

What they're measuring

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

Trial details

NCT IDNCT05385783

SponsorCybin IRL Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-16

View on ClinicalTrials.gov More Major Depressive Disorder trials

Who can participate

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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