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

• Status: Not yet recruiting
• Trial end date: 2023-07-23
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cybin IRL Limited
• Collaborators: Clinilabs Drug Development Corporation; Drug Safety Navigator

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.