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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05434156
Registration number
NCT05434156
Ethics application status
Date submitted
15/06/2022
Date registered
27/06/2022
Date last updated
16/08/2023
Titles & IDs
Public title
ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression
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Scientific 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 A Phase IIa, Open-Label Study to Evaluate a Range of Pharmacodynamic Effects of a Single Intravenous Dose of ELE-101 in Patients With Major Depressive Disorder (Part 2).
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Secondary ID [1]
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2022-000150-29
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Secondary ID [2]
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ET1001-ELE-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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Major Depressive Disorder
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Depression
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ELE-101
Treatment: Drugs - ELE-101 Placebo
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)
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)
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)
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)
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)
Experimental: Cohort 6 (Part 2) - A single TBD minute intravenous infusion of TBD mg ELE-101
Treatment: Drugs: ELE-101
ELE-101 solution for intravenous infusion
Treatment: Drugs: ELE-101 Placebo
ELE-101 placebo matching solution for intravenous infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Percentage of participants with at least one safety event
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to Day 8
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Primary outcome [2]
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Part 2: Subjective Drug Intensity Ratings
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Assessment method [2]
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- The SDI questionnaire will be used to rate the real-time intensity of the psychedelic experience
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Timepoint [2]
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pre-dose and at multiple time-points up to 24 hours post-dose
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Secondary outcome [1]
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Part 1 and 2: Cmax: Maximum observed plasma concentration for ELE-101 and its metabolites
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Assessment method [1]
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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Timepoint [1]
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pre-dose and at multiple time-points up to 24 hours post-dose
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Secondary outcome [2]
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Part 1 and 2: Tmax: Time to reach maximum plasma concentration (Cmax) for ELE-101 and its metabolites
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Assessment method [2]
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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Timepoint [2]
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pre-dose and at multiple time-points up to 24 hours post-dose
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Secondary outcome [3]
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Part 1 and 2: AUCinf: Area under the plasma concentration-time curve from Time 0 to Infinity for ELE-101 and its metabolites
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Assessment method [3]
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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Timepoint [3]
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pre-dose and at multiple time-points up to 24 hours post-dose
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Secondary outcome [4]
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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
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Assessment method [4]
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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Timepoint [4]
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pre-dose and at multiple time-points up to 24 hours post-dose
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Secondary outcome [5]
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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
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Assessment method [5]
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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Timepoint [5]
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pre-dose and at multiple time-points up to 24 hours post-dose
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Secondary outcome [6]
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Part 1 and 2: VZ: volume of distribution during the terminal disposition phase for ELE-101 and its metabolites
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Assessment method [6]
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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Timepoint [6]
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pre-dose and at multiple time-points up to 24 hours post-dose
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Secondary outcome [7]
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Part 1 and 2: VZss: volume of distribution at steady state for ELE-101 and its metabolites
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Assessment method [7]
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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Timepoint [7]
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pre-dose and at multiple time-points up to 24 hours post-dose
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Secondary outcome [8]
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Part 1 and 2: Cl: apparent total clearance from plasma for ELE-101 and its metabolites
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Assessment method [8]
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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Timepoint [8]
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pre-dose and at multiple time-points up to 24 hours post-dose
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Secondary outcome [9]
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Part 1 and 2: MRTinf: mean residence time from Time 0 to Infinity for ELE-101 and its metabolites
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Assessment method [9]
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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Timepoint [9]
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pre-dose and at multiple time-points up to 24 hours post-dose
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Secondary outcome [10]
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Part 1 and 2: t1/2: Terminal disposition phase half-life for ELE-101 and its metabolites
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Assessment method [10]
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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Timepoint [10]
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pre-dose and at multiple time-points up to 24 hours post-dose
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Secondary outcome [11]
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Part 1 and 2: Dischargeability: Assessment of subject-discharge readiness
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Assessment method [11]
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The dischargeability evaluation will be based on Investigator judgement after review of participant safety data.
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Timepoint [11]
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post-dose and 24 hours post-dose
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Secondary outcome [12]
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Part 1: The dose related psychoactive effects of ELE-101 as evaluated by a Visual Analogue Scale
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Assessment method [12]
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The Subjective Drug Intensity (SDI) is a Visual Analogue Scale scored from 0-10.
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Timepoint [12]
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pre-dose and at multiple time-points up to 24 hours post-dose
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Secondary outcome [13]
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Part 2: The effects of ELE-101 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline up to Day 29
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Secondary outcome [14]
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Part 2: Percentage of participants with at least one safety event
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline up to Day 29
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/10/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2023
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Actual
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Sample size
Target
84
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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CMAX - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment outside Australia
Country [1]
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United Kingdom
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State/province [1]
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Liverpool
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Country [2]
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United Kingdom
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State/province [2]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eleusis Therapeutics
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Beckley Psytech Pty Ltd
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05434156
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Gregory, MD
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Address
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MAC Clinical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Beckley Psytech Ltd
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Address
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Country
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Phone
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+44 (0)1865 987633
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05434156
Download to PDF