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Active, Not Recruiting

NCT Number: NCT05434156

ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression

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 patients with depression (Part 2).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Volunteers Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

MAC Clinical Research, Liverpool, United Kingdom

Loading trial locations.

About this study

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 drug intensity (SDI) of single ascending intravenous (IV) doses of ELE-101 in healthy male and female adult participants. Part 2 is a Phase IIa, open-label study to evaluate a range of pharmacodynamic effects of a single intravenous dose of ELE-101 in patients with depression.

Healthy participants will receive either ELE-101 or placebo as an IV infusion in Part 1 and patients with MDD will receive ELE-101 as an IV infusion in Part 2.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

ELE-101

Drug

ELE-101 solution for intravenous infusion

ELE-101 Placebo

Drug

ELE-101 placebo matching solution for intravenous infusion

Primary outcomes

  1. Part 1: Percentage of participants with at least one safety event

    Time frame: Baseline up to Day 8

    • Safety will be evaluated by the monitoring of adverse events (AEs), vital signs, blood pressure, heart rate, pulse oximetry, electrocardiogram (ECG) evaluations, clinical laboratory assessments, injection site reactions and physical examination findings.
    • Suicidal ideation and behavior will be evaluated using the Columbia-Suicide Severity Rating Scale (C-SSRS).
    • Percentage of participants who experience at least one treatment-emergent adverse event (TEAE) will be captured.
    • Tolerability will be measured using the SDI questionnaires to rate the intensity of the psychedelic experience alongside recordings of anticipated adverse effects such as nausea and headache.

  2. Part 2: Subjective Drug Intensity Ratings

    Time frame: pre-dose and at multiple time-points up to 24 hours post-dose

    • The SDI questionnaire will be used to rate the real-time intensity of the psychedelic experience

Secondary outcomes

  1. Part 1 and 2: Cmax: Maximum observed plasma concentration for ELE-101 and its metabolites

    Time frame: pre-dose and at multiple time-points up to 24 hours post-dose

    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study

  2. Part 1 and 2: Tmax: Time to reach maximum plasma concentration (Cmax) for ELE-101 and its metabolites

    Time frame: pre-dose and at multiple time-points up to 24 hours post-dose

    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study

  3. Part 1 and 2: AUCinf: Area under the plasma concentration-time curve from Time 0 to Infinity for ELE-101 and its metabolites

    Time frame: pre-dose and at multiple time-points up to 24 hours post-dose

    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study

  4. Part 1 and 2: AUClast: Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration for ELE-101 and its metabolites

    Time frame: pre-dose and at multiple time-points up to 24 hours post-dose

    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study

  5. Part 1 and 2: AUC0-24: Area under the plasma concentration-time curve from Time 0 to 24 hours for ELE-101 and its metabolites

    Time frame: pre-dose and at multiple time-points up to 24 hours post-dose

    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study

  6. Part 1 and 2: VZ: volume of distribution during the terminal disposition phase for ELE-101 and its metabolites

    Time frame: pre-dose and at multiple time-points up to 24 hours post-dose

    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study

  7. Part 1 and 2: VZss: volume of distribution at steady state for ELE-101 and its metabolites

    Time frame: pre-dose and at multiple time-points up to 24 hours post-dose

    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study

  8. Part 1 and 2: Cl: apparent total clearance from plasma for ELE-101 and its metabolites

    Time frame: pre-dose and at multiple time-points up to 24 hours post-dose

    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study

  9. Part 1 and 2: MRTinf: mean residence time from Time 0 to Infinity for ELE-101 and its metabolites

    Time frame: pre-dose and at multiple time-points up to 24 hours post-dose

    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study

  10. Part 1 and 2: t1/2: Terminal disposition phase half-life for ELE-101 and its metabolites

    Time frame: pre-dose and at multiple time-points up to 24 hours post-dose

    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study

  11. Part 1 and 2: Dischargeability: Assessment of subject-discharge readiness

    Time frame: post-dose and 24 hours post-dose

    The dischargeability evaluation will be based on Investigator judgement after review of participant safety data.

  12. Part 1: The dose related psychoactive effects of ELE-101 as evaluated by a Visual Analogue Scale

    Time frame: pre-dose and at multiple time-points up to 24 hours post-dose

    The Subjective Drug Intensity (SDI) is a Visual Analogue Scale scored from 0-10.

  13. Part 2: The effects of ELE-101 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: Baseline up to Day 85

    The MADRS is a diagnostic questionnaire with ten items for measuring the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item is scored from 0 to 6. The overall score ranges from 0 to 60.

  14. Part 2: Percentage of participants with at least one safety event

    Time frame: Baseline up to Day 85

    • Safety will be evaluated by the monitoring of adverse events (AEs), vital signs, blood pressure, heart rate, pulse oximetry, electrocardiogram (ECG) evaluations, clinical laboratory assessments, injection site reactions and physical examination findings.
    • Suicidal ideation and behavior will be evaluated using the Columbia-Suicide Severity Rating Scale (C-SSRS).
    • Percentage of participants who experience at least one treatment-emergent adverse event (TEAE) will be captured.
    • Tolerability will be measured using the SDI questionnaires to rate the intensity of the psychedelic experience alongside recordings of anticipated adverse effects such as nausea and headache.

Sponsors and collaborators

Lead sponsor

Eleusis Therapeutics

Industry

Collaborators

  • Beckley Psytech Limited

Registry information

Official study title

A Phase I, Randomised, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Intravenous Doses of ELE-101 in Healthy Adult Participants (Part 1) and Part 2, Open-Label Study to Evaluate a Range of Pharmacodynamic Effects of a Single Intravenous Dose of ELE-101 in Patients With Major Depressive Disorder.

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 27, 2022
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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