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

NCT05434156 | Active Not Recruiting Phase 1

• 2 other identifiers: ET1001-ELE-1012022-000150-29
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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 patients with depression (Part 2).

Conditions

Healthy Volunteers; Major Depressive Disorder; Depression

Keywords

ELE-101; psilocin; ELE-Psilo; psilocybin; psychedelic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

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

  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

  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

  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

  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

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

Study Arms (6)

Cohort 1 (Part 1)

EXPERIMENTAL

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

Cohort 2 (Part 1)

EXPERIMENTAL

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

Cohort 3 (Part 1)

EXPERIMENTAL

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

Cohort 4 (Part 1)

EXPERIMENTAL

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

Cohort 5 (Part 1)

EXPERIMENTAL

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

Cohort 6 (Part 2)

EXPERIMENTAL

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

Drug: ELE-101

Interventions

ELE-101 DRUG

ELE-101 solution for intravenous infusion

Cohort 1 (Part 1); Cohort 2 (Part 1); Cohort 3 (Part 1); Cohort 4 (Part 1); Cohort 5 (Part 1); Cohort 6 (Part 2)

ELE-101 Placebo DRUG

ELE-101 placebo matching solution for intravenous infusion

Cohort 1 (Part 1); Cohort 2 (Part 1); Cohort 3 (Part 1); Cohort 4 (Part 1); Cohort 5 (Part 1)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eleusis Therapeutics: lead
• Beckley Psytech Limited: collaborator

Study Sites (2)

MAC Clinical Research

Liverpool, L34 1BH, United Kingdom

Location

MAC Clinical Research

Manchester, M13 9NQ, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Neel Bhatt

  MAC Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Open label in Part 2
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 27, 2022
• Study Start: October 27, 2022
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)