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Healthy VolunteersPhase 1/2NCT05434156

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

A Phase 1/2 study testing ELE-101 in people with Healthy Volunteers and Major Depressive Disorder, run by Eleusis Therapeutics at 2 sites in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
ELE-101
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
2 sitesUnited Kingdom
Study dates
27 Oct 2022to Mar 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • MAC Clinical Research

    Liverpool, L34 1BH

  • MAC Clinical Research

    Manchester, M13 9NQ

Other trials in United Kingdom

About this study

Official 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.

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.

Being tested
ELE-101, ELE-101 Placebo
Keywords
ELE-101, psilocin, ELE-Psilo, psilocybin, psychedelic
Medical subject headings
Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ELE-101Drug

    ELE-101 solution for intravenous infusion

  • ELE-101 PlaceboDrug

    ELE-101 placebo matching solution for intravenous infusion

Study groups in NCT05434156
Study groupRoleWhat they receive
Cohort 1 (Part 1)ExperimentalA single 10-minute intravenous infusion of 0.25 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
Receives: Drug: ELE-101; Drug: ELE-101 Placebo
Cohort 2 (Part 1)ExperimentalA single 10-minute intravenous infusion of 0.75 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
Receives: Drug: ELE-101; Drug: ELE-101 Placebo
Cohort 3 (Part 1)ExperimentalA single 10-minute intravenous infusion of 2.0 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
Receives: Drug: ELE-101; Drug: ELE-101 Placebo
Cohort 4 (Part 1)ExperimentalA single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
Receives: Drug: ELE-101; Drug: ELE-101 Placebo
Cohort 5 (Part 1)ExperimentalA single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
Receives: Drug: ELE-101; Drug: ELE-101 Placebo
Cohort 6 (Part 2)ExperimentalA single TBD minute intravenous infusion of TBD mg ELE-101
Receives: Drug: ELE-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

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

Secondary outcomes (14)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline up to Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start27 Oct 2022
  3. Primary completionDec 2025 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05434156
Sponsor's protocol ID
ET1001-ELE-101
Other IDs
2022-000150-29
Status last verified
Feb 2025
First submitted
15 Jun 2022
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ELE-101 in people with Healthy Volunteers and Major Depressive Disorder, run by Eleusis Therapeutics at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Percentage of participants with at least one safety event (time frame: Baseline up to Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05434156.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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