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ELE-101 Safety & Tolerability Study in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05434156
Recruitment Status : Not yet recruiting
First Posted : June 27, 2022
Last Update Posted : August 4, 2022
Sponsor:
Information provided by (Responsible Party):
Eleusis Therapeutics

Tracking Information
First Submitted Date  ICMJE June 15, 2022
First Posted Date  ICMJE June 27, 2022
Last Update Posted Date August 4, 2022
Estimated Study Start Date  ICMJE August 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2022)
Percentage of participants with at least one safety event [ Time Frame: Baseline up to Day 8 ]
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2022)
  • Cmax: Maximum observed plasma concentration for ELE-101 and its metabolites [ Time Frame: pre-dose and at multiple time-points up to 24 hours post-dose ]
    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
  • Tmax: Time to reach maximum plasma concentration (Cmax) for ELE-101 and its metabolites [ Time Frame: pre-dose and at multiple time-points up to 24 hours post-dose ]
    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
  • AUCinf: Area under the plasma concentration-time curve from Time 0 to Infinity for ELE-101 and its metabolites [ Time Frame: pre-dose and at multiple time-points up to 24 hours post-dose ]
    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
  • 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 [ Time Frame: pre-dose and at multiple time-points up to 24 hours post-dose ]
    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
  • AUC0-24: Area under the plasma concentration-time curve from Time 0 to 24 hours for ELE-101 and its metabolites [ Time Frame: pre-dose and at multiple time-points up to 24 hours post-dose ]
    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
  • VZ: volume of distribution during the terminal disposition phase for ELE-101 and its metabolites [ Time Frame: pre-dose and at multiple time-points up to 24 hours post-dose ]
    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
  • VZss: volume of distribution at steady state for ELE-101 and its metabolites [ Time Frame: pre-dose and at multiple time-points up to 24 hours post-dose ]
    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
  • Cl: apparent total clearance from plasma for ELE-101 and its metabolites [ Time Frame: pre-dose and at multiple time-points up to 24 hours post-dose ]
    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
  • MRTinf: mean residence time from Time 0 to Infinity for ELE-101 and its metabolites [ Time Frame: pre-dose and at multiple time-points up to 24 hours post-dose ]
    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
  • t1/2: Terminal disposition phase half-life for ELE-101 and its metabolites [ Time Frame: pre-dose and at multiple time-points up to 24 hours post-dose ]
    PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
  • Dischargeability: Assessment of subject-discharge readiness [ Time Frame: post-dose and 24 hours post-dose ]
    The dischargeability evaluation will be based on Investigator judgement after review of participant safety data.
  • The dose related psychoactive effects of ELE-101 as evaluated by a Visual Analogue Scale [ Time Frame: pre-dose and at multiple time-points up to 24 hours post-dose ]
    The Subjective Drug Intensity (SDI) is a Visual Analogue Scale scored from 0-10.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ELE-101 Safety & Tolerability Study in Healthy Participants
Official Title  ICMJE 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.
Brief Summary A study in healthy adult participants 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.
Detailed Description

This 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.

Participants will receive either ELE-101 or placebo as an IV infusion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: ELE-101
    ELE-101 solution for intravenous infusion
  • Drug: ELE-101 Placebo
    ELE-101 placebo matching solution for intravenous infusion
Study Arms  ICMJE
  • Experimental: Cohort 1
    A single 10-minute intravenous infusion of 0.25 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
    Interventions:
    • Drug: ELE-101
    • Drug: ELE-101 Placebo
  • Experimental: Cohort 2
    A single 10-minute intravenous infusion of 0.75 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
    Interventions:
    • Drug: ELE-101
    • Drug: ELE-101 Placebo
  • Experimental: Cohort 3
    A single 10-minute intravenous infusion of 2.0 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
    Interventions:
    • Drug: ELE-101
    • Drug: ELE-101 Placebo
  • Experimental: Cohort 4
    A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
    Interventions:
    • Drug: ELE-101
    • Drug: ELE-101 Placebo
  • Experimental: Cohort 5
    A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
    Interventions:
    • Drug: ELE-101
    • Drug: ELE-101 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2022)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
  • Ongoing current MDD, or history of MDD within the last year.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: MAC Clinical Research +44 800 121 6394 info@researchforyou.co.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05434156
Other Study ID Numbers  ICMJE ET1001-ELE-101
2022-000150-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Eleusis Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eleusis Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fabian Devlin, MD MAC Clinical Research
PRS Account Eleusis Therapeutics
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP