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Active, not recruitingNCT05434156Updated Feb 19, 2025

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

A Phase 1/2 interventional study of ELE-101 and ELE-101 Placebo in Healthy Volunteers, Major Depressive Disorder and Depression, sponsored by Eleusis Therapeutics. Active, not recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Eleusis Therapeutics · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 1/2
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 patients with depression (Part 2).

Read the 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 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.

02

Conditions studied

  • Healthy Volunteers
  • Major Depressive Disorder
  • Depression

Keywords

  • ELE-101
  • psilocin
  • ELE-Psilo
  • psilocybin
  • psychedelic
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 84 is close to the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Eleusis Therapeutics is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    Cohort 1 (Part 1)

    A single 10-minute intravenous infusion of 0.25 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)

    Drug: ELE-101 · Drug: ELE-101 Placebo

  • Experimental
    Cohort 2 (Part 1)

    A single 10-minute intravenous infusion of 0.75 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)

    Drug: ELE-101 · Drug: ELE-101 Placebo

  • Experimental
    Cohort 3 (Part 1)

    A single 10-minute intravenous infusion of 2.0 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)

    Drug: ELE-101 · Drug: ELE-101 Placebo

  • Experimental
    Cohort 4 (Part 1)

    A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)

    Drug: ELE-101 · Drug: ELE-101 Placebo

  • Experimental
    Cohort 5 (Part 1)

    A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)

    Drug: ELE-101 · Drug: ELE-101 Placebo

  • Experimental
    Cohort 6 (Part 2)

    A single TBD minute intravenous infusion of TBD mg ELE-101

    Drug: ELE-101

Interventions

  • DrugELE-101

    ELE-101 solution for intravenous infusion

  • DrugELE-101 Placebo

    ELE-101 placebo matching solution for intravenous infusion

06

What researchers measure

Primary outcomes

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

    * 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.

    Time frame: Baseline up to Day 8

  2. Part 2: Subjective Drug Intensity Ratings

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

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

Secondary outcomes

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

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

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

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

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

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

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

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

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

  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

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

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

  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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    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.

    Time frame: Baseline up to Day 85

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

    * 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.

    Time frame: Baseline up to Day 85

07

Study locations

2 sites
  • MAC Clinical Research
    Liverpool, L34 1BH, United Kingdom
  • MAC Clinical Research
    Manchester, M13 9NQ, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05434156
Lead sponsor
Eleusis Therapeutics
Collaborators
Beckley Psytech Limited
Responsible party
Sponsor
First posted
Jun 27, 2022
Start date
Oct 27, 2022
Primary completion
Dec 2025 (estimated)
Completion
Mar 2026 (estimated)
Last update
Feb 19, 2025

Study contacts

Neel Bhatt
principal investigator · MAC Clinical Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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