ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression

Phase 2Active Not RecruitingNCT05434156

Eleusis Therapeutics84 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers Major Depressive Disorder Depression

Interventions

ELE-101DRUG

ELE-101 solution for intravenous infusion

ELE-101 PlaceboDRUG

ELE-101 placebo matching solution for intravenous infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

MAC Clinical Research

Liverpool, United Kingdom

MAC Clinical Research

Manchester, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Baseline up to Day 8

Part 2: Subjective Drug Intensity Ratings

\- The SDI questionnaire will be used to rate the real-time intensity of the psychedelic experience