Trial Review

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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
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).
Secondary ID [1] 0 0
2022-000150-29
Secondary ID [2] 0 0
ET1001-ELE-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Major Depressive Disorder 0 0
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Percentage of participants with at least one safety event
Timepoint [1] 0 0
Baseline up to Day 8
Primary outcome [2] 0 0
Part 2: Subjective Drug Intensity Ratings
Timepoint [2] 0 0
pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcome [1] 0 0
Part 1 and 2: Cmax: Maximum observed plasma concentration for ELE-101 and its metabolites
Timepoint [1] 0 0
pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcome [2] 0 0
Part 1 and 2: Tmax: Time to reach maximum plasma concentration (Cmax) for ELE-101 and its metabolites
Timepoint [2] 0 0
pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcome [3] 0 0
Part 1 and 2: AUCinf: Area under the plasma concentration-time curve from Time 0 to Infinity for ELE-101 and its metabolites
Timepoint [3] 0 0
pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcome [6] 0 0
Part 1 and 2: VZ: volume of distribution during the terminal disposition phase for ELE-101 and its metabolites
Timepoint [6] 0 0
pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcome [7] 0 0
Part 1 and 2: VZss: volume of distribution at steady state for ELE-101 and its metabolites
Timepoint [7] 0 0
pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcome [8] 0 0
Part 1 and 2: Cl: apparent total clearance from plasma for ELE-101 and its metabolites
Timepoint [8] 0 0
pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcome [9] 0 0
Part 1 and 2: MRTinf: mean residence time from Time 0 to Infinity for ELE-101 and its metabolites
Timepoint [9] 0 0
pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcome [10] 0 0
Part 1 and 2: t1/2: Terminal disposition phase half-life for ELE-101 and its metabolites
Timepoint [10] 0 0
pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcome [11] 0 0
Part 1 and 2: Dischargeability: Assessment of subject-discharge readiness
Timepoint [11] 0 0
post-dose and 24 hours post-dose
Secondary outcome [12] 0 0
Part 1: The dose related psychoactive effects of ELE-101 as evaluated by a Visual Analogue Scale
Timepoint [12] 0 0
pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcome [13] 0 0
Part 2: The effects of ELE-101 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [13] 0 0
Baseline up to Day 29
Secondary outcome [14] 0 0
Part 2: Percentage of participants with at least one safety event
Timepoint [14] 0 0
Baseline up to Day 29

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Liverpool
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eleusis Therapeutics
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Beckley Psytech Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05434156
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Gregory, MD
Address 0 0
MAC Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Beckley Psytech Ltd
Address 0 0
Country 0 0
Phone 0 0
+44 (0)1865 987633
Fax 0 0
Email 0 0
Medinfo@beckleypsytech.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05434156