Clinical trial NCT05434156: 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 Part 2, Open-Label Study to Evaluate a Range of Pharmacodynamic Effects of a Single Intravenous Dose of ELE-101 in Patients With Major Depressive Disorder.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteers
Major Depressive Disorder
Depression
Keywords: ELE-101
psilocin
ELE-Psilo
psilocybin
psychedelic
Lead sponsor: Eleusis Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Beckley Psytech Limited
First posted: 2022-06-27
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Part 1: Percentage of participants with at least one safety event
timeFrame: Baseline up to Day 8
measure: Part 2: Subjective Drug Intensity Ratings
timeFrame: pre-dose and at multiple time-points up to 24 hours post-dose
Secondary outcomes:
measure: Part 1 and 2: Cmax: Maximum observed plasma concentration for ELE-101 and its metabolites
timeFrame: pre-dose and at multiple time-points up to 24 hours post-dose
measure: Part 1 and 2: Tmax: Time to reach maximum plasma concentration (Cmax) for ELE-101 and its metabolites
timeFrame: pre-dose and at multiple time-points up to 24 hours post-dose
measure: Part 1 and 2: AUCinf: Area under the plasma concentration-time curve from Time 0 to Infinity for ELE-101 and its metabolites
timeFrame: pre-dose and at multiple time-points up to 24 hours post-dose
measure: 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
timeFrame: pre-dose and at multiple time-points up to 24 hours post-dose
measure: 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
timeFrame: pre-dose and at multiple time-points up to 24 hours post-dose
measure: Part 1 and 2: VZ: volume of distribution during the terminal disposition phase for ELE-101 and its metabolites
timeFrame: pre-dose and at multiple time-points up to 24 hours post-dose
measure: Part 1 and 2: VZss: volume of distribution at steady state for ELE-101 and its metabolites
timeFrame: pre-dose and at multiple time-points up to 24 hours post-dose
measure: Part 1 and 2: Cl: apparent total clearance from plasma for ELE-101 and its metabolites
timeFrame: pre-dose and at multiple time-points up to 24 hours post-dose
measure: Part 1 and 2: MRTinf: mean residence time from Time 0 to Infinity for ELE-101 and its metabolites
timeFrame: pre-dose and at multiple time-points up to 24 hours post-dose
measure: Part 1 and 2: t1/2: Terminal disposition phase half-life for ELE-101 and its metabolites
timeFrame: pre-dose and at multiple time-points up to 24 hours post-dose
measure: Part 1 and 2: Dischargeability: Assessment of subject-discharge readiness
timeFrame: post-dose and 24 hours post-dose
measure: Part 1: The dose related psychoactive effects of ELE-101 as evaluated by a Visual Analogue Scale
timeFrame: pre-dose and at multiple time-points up to 24 hours post-dose
measure: Part 2: The effects of ELE-101 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline up to Day 85
measure: Part 2: Percentage of participants with at least one safety event
timeFrame: Baseline up to Day 85
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: MAC Clinical Research
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
Study officials:
affiliation: MAC Clinical Research
name: Neel Bhatt
role: PRINCIPAL_INVESTIGATOR
References: