Status:
ACTIVE_NOT_RECRUITING
ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression
Lead Sponsor:
Eleusis Therapeutics
Collaborating Sponsors:
Beckley Psytech Limited
Conditions:
Healthy Volunteers
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
A study to assess the safety and tolerability of a drug called ELE-101 and see how the body absorbs and removes the drug and how it affects the body in healthy adult participants (Part 1) and in patie...
Detailed Description
This is a 2-part study. Part 1 is a phase I, double-blind, placebo-controlled, randomized study to assess the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) and subjective dr...
Eligibility Criteria
Inclusion
- Healthy male or female participants aged 18 to 65 years, inclusive.
- Participants have a body mass index (BMI) of 18 to 35 kg/m2, inclusive.
- Participants are able and willing to give written informed consent, adhere to the compliance terms during participation in the study, undergo the examinations and testing set forth in the study Protocol and clearly and reliably communicate their subjective symptoms to the Investigator.
- Part 2 Only: Patient has a diagnosis of MDD and is not on antidepressant medication.
Exclusion
- Current, or history (within the last 6 months) of, alcohol or substance use disorder.
- Use of pharmacological compounds for psychiatric or neurological conditions acting on the CNS within 30 days or 5 half-lives (whichever is longer) prior to Screening.
- Current or clinically relevant history of schizophrenia, psychotic, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder or panic disorder.
- In first-degree relatives, a history of schizophrenia, psychosis, bipolar disorder, delusional disorder, paranoid personality disorder or schizoaffective disorder.
- History of a diagnosis of Hallucinogen Persistent Perceptual Disorder (HPPD).
- Significant suicide risk.
- Other personal circumstances and behavior that is incompatible with establishment of rapport or safe exposure to psilocin, as judged by the Investigator.
- Part 1 Only: Ongoing current MDD, or history of MDD within the last year.
Key Trial Info
Start Date :
October 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05434156
Start Date
October 27 2022
End Date
March 1 2026
Last Update
February 19 2025
Active Locations (2)
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1
MAC Clinical Research
Liverpool, United Kingdom, L34 1BH
2
MAC Clinical Research
Manchester, United Kingdom, M13 9NQ