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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Healthy Volunteers; Major Depressive Disorder
• Intervention / Treatment: Drug: ELE-101; Drug: ELE-101 Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; ELE-101 solution for intravenous infusion; Drug: ELE-101 Placebo; ELE-101 placebo matching solution for intravenous infusion
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; ELE-101 solution for intravenous infusion; Drug: ELE-101 Placebo; ELE-101 placebo matching solution for intravenous infusion
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; ELE-101 solution for intravenous infusion; Drug: ELE-101 Placebo; ELE-101 placebo matching solution for intravenous infusion
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; ELE-101 solution for intravenous infusion; Drug: ELE-101 Placebo; ELE-101 placebo matching solution for intravenous infusion
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; ELE-101 solution for intravenous infusion; Drug: ELE-101 Placebo; ELE-101 placebo matching solution for intravenous infusion
Experimental: Cohort 6 (Part 2); A single TBD minute intravenous infusion of TBD mg ELE-101	Drug: ELE-101; ELE-101 solution for intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to Day 8
Part 2: Subjective Drug Intensity Ratings	- The SDI questionnaire will be used to rate the real-time intensity of the psychedelic experience	pre-dose and at multiple time-points up to 24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pre-dose and at multiple time-points up to 24 hours post-dose
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	pre-dose and at multiple time-points up to 24 hours post-dose
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	pre-dose and at multiple time-points up to 24 hours post-dose
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	pre-dose and at multiple time-points up to 24 hours post-dose
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	pre-dose and at multiple time-points up to 24 hours post-dose
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	pre-dose and at multiple time-points up to 24 hours post-dose
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	pre-dose and at multiple time-points up to 24 hours post-dose
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	pre-dose and at multiple time-points up to 24 hours post-dose
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	pre-dose and at multiple time-points up to 24 hours post-dose
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	pre-dose and at multiple time-points up to 24 hours post-dose
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.	post-dose and 24 hours post-dose
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.	pre-dose and at multiple time-points up to 24 hours post-dose
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.	Baseline up to Day 85
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.	Baseline up to Day 85

Collaborators and Investigators

• Sponsor: Eleusis Therapeutics
• Collaborators: Beckley Psytech Limited
• Investigators: Principal Investigator: Neel Bhatt, MAC Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: psilocybin; psychedelic; psilocin; ELE-101; ELE-Psilo
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: ET1001-ELE-101; 2022-000150-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No