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A Study of a Psilocybin Analog (CYB003) in Participants With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05385783
Recruitment Status : Recruiting
First Posted : May 23, 2022
Last Update Posted : July 13, 2022
Sponsor:
Collaborators:
Clinilabs Drug Development Corporation
Drug Safety Navigator
Information provided by (Responsible Party):
Cybin IRL Limited

Brief Summary:
The purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in participants with major depressive disorder (MDD).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: CYB003 Behavioral: Psychotherapy Drug: Placebo Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of CYB003 in Participants With Major Depressive Disorder
Estimated Study Start Date : July 6, 2022
Estimated Primary Completion Date : July 23, 2023
Estimated Study Completion Date : July 23, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A: CYB003 Both Medicine Sessions
Arm A participants will receive CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. The CYB003 dose received will depend on the time of enrollment within one of up to 7 cohorts. All participants will receive supportive EMBARK psychotherapy throughout the study.
Drug: CYB003
CYB003 is a synthetic psilocybin analog.

Behavioral: Psychotherapy
Manualized psychotherapy (called EMBARK) performed by facilitators

Placebo Comparator: B: Placebo in Medicine Session 1, CYB003 in Medicine Session 2
Arm B 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 time of enrollment within one of up to 7 cohorts. All participants will receive supportive EMBARK psychotherapy throughout the study.
Drug: CYB003
CYB003 is a synthetic psilocybin analog.

Behavioral: Psychotherapy
Manualized psychotherapy (called EMBARK) performed by facilitators

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Day 1 thru Day 56 (End of Study Visit) ]
    Any untoward medical occurrence in a clinical investigation participant administered a drug and does not necessarily have a causal relationship with the treatment

  2. Resting 12 Lead ECG ventricular rate [ Time Frame: Screening ]
    ventricular rate (beats per minute)

  3. Resting 12 Lead ECG ventricular rate [ Time Frame: Day -1 ]
    ventricular rate (beats per minute)

  4. Resting 12 Lead ECG ventricular rate [ Time Frame: Day1 ]
    ventricular rate (beats per minute)

  5. Resting 12 Lead ECG ventricular rate [ Time Frame: Day 2 ]
    ventricular rate (beats per minute)

  6. Resting 12 Lead ECG ventricular rate [ Time Frame: Day 21 ]
    ventricular rate (beats per minute)

  7. Resting 12 Lead ECG ventricular rate [ Time Frame: Day 22 ]
    ventricular rate (beats per minute)

  8. Resting 12 Lead ECG ventricular rate [ Time Frame: Day 23 ]
    ventricular rate (beats per minute)

  9. Resting 12 Lead ECG PR interval [ Time Frame: Screening ]
    PR interval (milliseconds)

  10. Resting 12 Lead ECG PR interval [ Time Frame: Day -1 ]
    PR interval (milliseconds)

  11. Resting 12 Lead ECG PR interval [ Time Frame: Day 2 ]
    PR interval (milliseconds)

  12. Resting 12 Lead ECG PR interval [ Time Frame: Day 21 ]
    PR interval (milliseconds)

  13. Resting 12 Lead ECG PR interval [ Time Frame: Day 22 ]
    PR interval (milliseconds)

  14. Resting 12 Lead ECG PR interval [ Time Frame: Day 23 ]
    PR interval (milliseconds)

  15. Resting 12 Lead ECG QRS duration [ Time Frame: Screening ]
    QRS duration (milliseconds)

  16. Resting 12 Lead ECG QRS duration [ Time Frame: Day -1 ]
    QRS duration (milliseconds)

  17. Resting 12 Lead ECG QRS duration [ Time Frame: Day 1 ]
    QRS duration (milliseconds)

  18. Resting 12 Lead ECG QRS duration [ Time Frame: Day 2 ]
    QRS duration (milliseconds)

  19. Resting 12 Lead ECG QRS duration [ Time Frame: Day 21 ]
    QRS duration (milliseconds)

  20. Resting 12 Lead ECG QRS duration [ Time Frame: Day 22 ]
    QRS duration (milliseconds)

  21. Resting 12 Lead ECG QRS duration [ Time Frame: Day 23 ]
    QRS duration (milliseconds)

  22. Resting 12 Lead ECG QT interval [ Time Frame: Screening ]
    QT interval (milliseconds)

  23. Resting 12 Lead ECG QT interval [ Time Frame: Day -1 ]
    QT interval (milliseconds)

  24. Resting 12 Lead ECG QT interval [ Time Frame: Day 1 ]
    QT interval (milliseconds)

  25. Resting 12 Lead ECG QT interval [ Time Frame: Day 2 ]
    QT interval (milliseconds)

  26. Resting 12 Lead ECG QT interval [ Time Frame: Day 21 ]
    QT interval (milliseconds)

  27. Resting 12 Lead ECG QT interval [ Time Frame: Day 22 ]
    QT interval (milliseconds)

  28. Resting 12 Lead ECG QT interval [ Time Frame: Day 23 ]
    QT interval (milliseconds)

  29. Resting 12 Lead ECG QTcF [ Time Frame: Screening ]
    Corrected QT interval by Fredericia (milliseconds)

  30. Resting 12 Lead ECG QTcF [ Time Frame: Day -1 ]
    Corrected QT interval by Fredericia (milliseconds)

  31. Resting 12 Lead ECG QTcF [ Time Frame: Day 1 ]
    Corrected QT interval by Fredericia (milliseconds)

  32. Resting 12 Lead ECG QTcF [ Time Frame: Day 2 ]
    Corrected QT interval by Fredericia (milliseconds)

  33. Resting 12 Lead ECG QTcF [ Time Frame: Day 21 ]
    Corrected QT interval by Fredericia (milliseconds)

  34. Resting 12 Lead ECG QTcF [ Time Frame: Day 22 ]
    Corrected QT interval by Fredericia (milliseconds)

  35. Resting 12 Lead ECG QTcF [ Time Frame: Day 23 ]
    Corrected QT interval by Fredericia (milliseconds)

  36. Holter monitoring [ Time Frame: Day -1 ]
    Record of the electrical activity of the heart (Hz)

  37. Holter monitoring [ Time Frame: Day 1 ]
    Record of the electrical activity of the heart (Hz)

  38. Holter monitoring [ Time Frame: Day 22 ]
    Record of the electrical activity of the heart (Hz)

  39. Columbia Suicide Severity Rating Scale (CSSRS) Lifetime version [ Time Frame: 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).

  40. Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) [ Time Frame: Day -1 ]
    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).

  41. Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) [ Time Frame: Day 2 ]
    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).

  42. Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) [ Time Frame: Day 10 ]
    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).

  43. Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) [ Time Frame: Day 17 ]
    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).

  44. Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) [ Time Frame: Day 21 ]
    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).

  45. Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) [ Time Frame: Day 23 ]
    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).

  46. Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) [ Time Frame: Day 31 ]
    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).

  47. Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) [ Time Frame: Day 38 ]
    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).

  48. Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) [ Time Frame: Day 42 ]
    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).

  49. Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) [ Time Frame: 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).


Secondary Outcome Measures :
  1. Mystical Experience Questionnaire (MEQ30) [ Time Frame: Day 1 ]
    The revised MEQ30 consists of 30 questions looking back on the entirety of a medicine session, participants are asked to answer each question according to one's feelings, thoughts, and experiences at the time of the session. Each item is rated on a Likert scale (0-None/not at all to 5-Extreme, more than any other time in my life). The minimum score is 0 and the maximum score is 150 with higher scores indicating a greater degree of mystical experience. The MEQ total score is computed by taking the average response to all items.

  2. Mystical Experience Questionnaire (MEQ30) [ Time Frame: Day 22 ]
    The revised MEQ30 consists of 30 questions looking back on the entirety of a medicine session, participants are asked to answer each question according to one's feelings, thoughts, and experiences at the time of the session. each item rated on a Likert scale (0-None/not at all to 5-Extreme, more than any other time in my life). The minimum score is 0 and the maximum score is 150 with higher scores indicating a greater degree of mystical experience. The MEQ total score is computed by taking the average response to all items.

  3. 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) [ Time Frame: Day 1 ]
    The 5D-ASC consists of a set of 94 items that participants are asked to rate to what extent the statements apply to one's particular experience, compared to normal waking consciousness. This has 11 subscales and higher scores are indicative of good outcomes.

  4. 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) [ Time Frame: Day 22 ]
    The 5D-ASC consists of a set of 94 items that participants are asked to rate to what extent the statements apply to one's particular experience, compared to normal waking consciousness. This has 11 subscales and higher scores are indicative of good outcomes.

  5. Hallucinogen Rating Scale (HRS) [ Time Frame: Day 1 ]
    The HRS is a questionnaire with up to 100 items and is designed to assess the subjective effects of hallucinogenic substances. Responses to the majority of questions are on a 5 point intensity scale: 0=not at all; 1=slightly; 2=moderately; 3=quite a bit; and 4=extremely. Some questions have a slightly modified scale, and one question asks to rate the amount of time between when the drug was administered and feeling an effect from: no effect, 0 5 minutes, 5-15 minutes, 15-30 minutes, 30 60 minutes, or more than one hour. The minimum score is zero and maximum score is 400 with higher scores indicating greater hallucinogenic effect.

  6. Hallucinogen Rating Scale (HRS) [ Time Frame: Day 22 ]
    The HRS is a questionnaire with up to 100 items and is designed to assess the subjective effects of hallucinogenic substances. Responses to the majority of questions are on a 5 point intensity scale: 0=not at all; 1=slightly; 2=moderately; 3=quite a bit; and 4=extremely. Some questions have a slightly modified scale, and one question asks to rate the amount of time between when the drug was administered and feeling an effect from: no effect, 0 5 minutes, 5-15 minutes, 15-30 minutes, 30 60 minutes, or more than one hour. The minimum score is zero and maximum score is 400 with higher scores indicating greater hallucinogenic effect.

  7. Persisting Effects Questionnaire (PEQ) [ Time Frame: Day 1 ]
    The PEQ is a 5-item questionnaire that assesses the meaningfulness, spiritual significance, psychological insightfulness, and how psychologically challenging a participant experience was during the medicine session. Scores are assessed on a scale from 0 (not at all) to 5 (extremely). Higher scores (under consideration of reverse-scored items) indicate stronger persisting treatment effects.

  8. Persisting Effects Questionnaire (PEQ) [ Time Frame: Day 22 ]
    The PEQ is a 5-item questionnaire that assesses the meaningfulness, spiritual significance, psychological insightfulness, and how psychologically challenging a participant experience was during the medicine session. Scores are assessed on a scale from 0 (not at all) to 5 (extremely). Higher scores (under consideration of reverse-scored items) indicate stronger persisting treatment effects.

  9. VAS Ratings of "Any Drug Effect" [ Time Frame: Day 1 ]
    The visual analog scale (VAS) for "Any Drug Effect" consists of a 100mm bipolar line with the far-left side of the line marked "not at all" and the far-right side of the line marked "extremely" to assess if participants feel any drug effect.

  10. VAS Ratings of "Any Drug Effect" [ Time Frame: Day 22 ]
    The visual analog scale (VAS) for "Any Drug Effect" consists of a 100mm bipolar line with the far-left side of the line marked "not at all" and the far-right side of the line marked "extremely" to assess if participants feel any drug effect.

  11. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from screening [ Time Frame: Day 1 ]
    The minimum and maximum values are 0 and 60 with a higher score indicating a worse outcome.

  12. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from screening [ Time Frame: Day 2 ]
    The minimum and maximum values are 0 and 60 with a higher score indicating a worse outcome.

  13. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from screening [ Time Frame: Day 10 ]
    The minimum and maximum values are 0 and 60 with a higher score indicating a worse outcome.

  14. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from screening [ Time Frame: Day 17 ]
    The minimum and maximum values are 0 and 60 with a higher score indicating a worse outcome.

  15. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from screening [ Time Frame: Day 31 ]
    The minimum and maximum values are 0 and 60 with a higher score indicating a worse outcome.

  16. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from screening [ Time Frame: Day 38 ]
    The minimum and maximum values are 0 and 60 with a higher score indicating a worse outcome.

  17. Pharmacokinetic parameter of psilocin (Cmax) [ Time Frame: Day 1 ]
    Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data.

  18. Pharmacokinetic parameter of psilocin (Cmax) [ Time Frame: Day 2 ]
    Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data.

  19. Pharmacokinetic parameter of psilocin (Cmax) [ Time Frame: Day 22 ]
    Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data.

  20. Pharmacokinetic parameter of psilocin (Cmax) [ Time Frame: Day 23 ]
    Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data.

  21. Pharmacokinetic parameter of psilocin (AUC) [ Time Frame: Day 1 ]
    AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.

  22. Pharmacokinetic parameter of psilocin (AUC) [ Time Frame: Day 2 ]
    AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.

  23. Pharmacokinetic parameter of psilocin (AUC) [ Time Frame: Day 22 ]
    AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.

  24. Pharmacokinetic parameter of psilocin (AUC) [ Time Frame: Day 23 ]
    AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Inadequate response to current antidepressant medication, and absence of treatment- resistant depression, based on a diagnostic interview conducted by a clinician.
  • Aged between 21 to 55 years, inclusive, at Screening.
  • Has a BMI of 18 to 30 kg/m2, inclusive, at Screening.
  • Is ≥60 kg.
  • A non-smoker for at least the past 3 months with a negative urine cotinine test at Screening.
  • 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.
  • Registered with a healthcare professional who can confirm the diagnosis and previous treatments received by the participant.
  • Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

  • Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder; current or previous history of bipolar disorder, or current personality disorder.
  • Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview.
  • Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments given at an adequate dose for an adequate duration.
  • Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, mirtazapine, an antipsychotic or a mood stabilizer.
  • 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 current abnormal thyroid function tests.
  • Clinically relevant abnormal laboratory results.
  • Other eligibility considerations (i.e., participant personal circumstances, behavior, and/or any current problem that might interfere with participation or that is incompatible with establishment of rapport or safe exposure to the study drug), as judged by the Investigator.
  • History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
  • Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study.
  • Has a presence or relevant history of any of the following medical conditions: organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions).
  • Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti- HCV) or human immunodeficiency virus I and II (anti-HIV I/II) at Screening.
  • Has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to dosing of current study medication.
  • Use of a prescription medicine (except for stable chronic dose of antidepressant medication(s), sedatives/hypnotics, and hormonal contraceptives, if applicable), certain herbal supplements (to be reviewed by the Investigator), or over-the-counter (OTC) medicine, during the 28 days before dosing. Stable chronic therapy with hormone replacement medication is also allowed. The Investigator and study team may review medication on a case-by-case basis to determine if its use would compromise participant safety or interfere with study procedures or data interpretation.
  • Donation of blood or plasma of >400 mL within 1 month prior to first dosing until 4 weeks after final dosing.
  • Is pregnant, breastfeeding or planning to conceive.
  • Known difficulty with obtaining intravenous access.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05385783


Contacts
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Contact: Recruitment Manager (914)306-9017 getinvolved@clinilabs.com

Locations
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United States, New Jersey
Clinilabs Drug Development Corporation Recruiting
Eatontown, New Jersey, United States, 07724
Contact: Amber Farwig       afarwig@clinilabs.com   
Principal Investigator: Magdy L Shenouda, MD         
Sponsors and Collaborators
Cybin IRL Limited
Clinilabs Drug Development Corporation
Drug Safety Navigator
Investigators
Layout table for investigator information
Study Director: Amir Inamdar, MBBS,DNB,MFPM Cybin IRL Limited
Additional Information:
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Responsible Party: Cybin IRL Limited
ClinicalTrials.gov Identifier: NCT05385783    
Other Study ID Numbers: CYB003-001
First Posted: May 23, 2022    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cybin IRL Limited:
Major Depressive Disorder
MDD
Psilocybin
Psychedelic
Psilocin
CYB003
CYB003-001
Depression
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms