Back to resultsELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression
Primary Purpose
Healthy Volunteers, Major Depressive Disorder, Depression
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ELE-101
ELE-101 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Volunteers focused on measuring ELE-101, psilocin, ELE-Psilo, psilocybin, psychedelic
Eligibility Criteria
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.
Sites / Locations
- CMAX
- MAC Clinical ResearchRecruiting
- MAC Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1 (Part 1)
Cohort 2 (Part 1)
Cohort 3 (Part 1)
Cohort 4 (Part 1)
Cohort 5 (Part 1)
Cohort 6 (Part 2)
Arm Description
A single 10-minute intravenous infusion of 0.25 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
A single 10-minute intravenous infusion of 0.75 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
A single 10-minute intravenous infusion of 2.0 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
A single TBD minute intravenous infusion of TBD mg ELE-101
Outcomes
Primary Outcome Measures
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.
Part 2: Subjective Drug Intensity Ratings
- The SDI questionnaire will be used to rate the real-time intensity of the psychedelic experience
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
Full Information
NCT ID
NCT05434156
First Posted
June 15, 2022
Last Updated
August 14, 2023
Sponsor
Eleusis Therapeutics
Collaborators
Beckley Psytech Pty Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05434156
Brief Title
ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression
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 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).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eleusis Therapeutics
Collaborators
Beckley Psytech Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Major Depressive Disorder, Depression
Keywords
ELE-101, psilocin, ELE-Psilo, psilocybin, psychedelic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Open label in Part 2
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 (Part 1)
Arm Type
Experimental
Arm Description
A single 10-minute intravenous infusion of 0.25 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
Arm Title
Cohort 2 (Part 1)
Arm Type
Experimental
Arm Description
A single 10-minute intravenous infusion of 0.75 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
Arm Title
Cohort 3 (Part 1)
Arm Type
Experimental
Arm Description
A single 10-minute intravenous infusion of 2.0 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
Arm Title
Cohort 4 (Part 1)
Arm Type
Experimental
Arm Description
A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
Arm Title
Cohort 5 (Part 1)
Arm Type
Experimental
Arm Description
A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
Arm Title
Cohort 6 (Part 2)
Arm Type
Experimental
Arm Description
A single TBD minute intravenous infusion of TBD mg ELE-101
Intervention Type
Drug
Intervention Name(s)
ELE-101
Intervention Description
ELE-101 solution for intravenous infusion
Intervention Type
Drug
Intervention Name(s)
ELE-101 Placebo
Intervention Description
ELE-101 placebo matching solution for intravenous infusion
Primary Outcome Measure Information:
Title
Part 1: Percentage of participants with at least one safety event
Description
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
Title
Part 2: Subjective Drug Intensity Ratings
Description
- 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 Outcome Measure Information:
Title
Part 1 and 2: Cmax: Maximum observed plasma concentration for ELE-101 and its metabolites
Description
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
Title
Part 1 and 2: Tmax: Time to reach maximum plasma concentration (Cmax) for ELE-101 and its metabolites
Description
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
Title
Part 1 and 2: AUCinf: Area under the plasma concentration-time curve from Time 0 to Infinity for ELE-101 and its metabolites
Description
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
Title
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
Description
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
Title
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
Description
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
Title
Part 1 and 2: VZ: volume of distribution during the terminal disposition phase for ELE-101 and its metabolites
Description
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
Title
Part 1 and 2: VZss: volume of distribution at steady state for ELE-101 and its metabolites
Description
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
Title
Part 1 and 2: Cl: apparent total clearance from plasma for ELE-101 and its metabolites
Description
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
Title
Part 1 and 2: MRTinf: mean residence time from Time 0 to Infinity for ELE-101 and its metabolites
Description
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
Title
Part 1 and 2: t1/2: Terminal disposition phase half-life for ELE-101 and its metabolites
Description
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
Title
Part 1 and 2: Dischargeability: Assessment of subject-discharge readiness
Description
The dischargeability evaluation will be based on Investigator judgement after review of participant safety data.
Time Frame
post-dose and 24 hours post-dose
Title
Part 1: The dose related psychoactive effects of ELE-101 as evaluated by a Visual Analogue Scale
Description
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
Title
Part 2: The effects of ELE-101 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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 29
Title
Part 2: Percentage of participants with at least one safety event
Description
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 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beckley Psytech Ltd
Phone
+44 (0)1865 987633
Email
Medinfo@beckleypsytech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gregory, MD
Organizational Affiliation
MAC Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMAX
City
Adelaide
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sepher Shakib
Email
cmax@cmax.com.au
Facility Name
MAC Clinical Research
City
Liverpool
ZIP/Postal Code
L34 1BH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Gregory
Email
info@researchforyou.co.uk
Facility Name
MAC Clinical Research
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ezanul Wahab
Email
info@researchforyou.co.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression
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