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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2026-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Healthy Volunteers Major Depressive Disorder Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Open label in Part 2

Study Groups

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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)

Group Type EXPERIMENTAL

ELE-101

Intervention Type DRUG

ELE-101 solution for intravenous infusion

ELE-101 Placebo

Intervention Type DRUG

ELE-101 placebo matching solution for intravenous infusion

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)

Group Type EXPERIMENTAL

ELE-101

Intervention Type DRUG

ELE-101 solution for intravenous infusion

ELE-101 Placebo

Intervention Type DRUG

ELE-101 placebo matching solution for intravenous infusion

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)

Group Type EXPERIMENTAL

ELE-101

Intervention Type DRUG

ELE-101 solution for intravenous infusion

ELE-101 Placebo

Intervention Type DRUG

ELE-101 placebo matching solution for intravenous infusion

Cohort 4 (Part 1)

A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)

Group Type EXPERIMENTAL

ELE-101

Intervention Type DRUG

ELE-101 solution for intravenous infusion

ELE-101 Placebo

Intervention Type DRUG

ELE-101 placebo matching solution for intravenous infusion

Cohort 5 (Part 1)

A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)

Group Type EXPERIMENTAL

ELE-101

Intervention Type DRUG

ELE-101 solution for intravenous infusion

ELE-101 Placebo

Intervention Type DRUG

ELE-101 placebo matching solution for intravenous infusion

Cohort 6 (Part 2)

A single TBD minute intravenous infusion of TBD mg ELE-101

Group Type EXPERIMENTAL

ELE-101

Intervention Type DRUG

ELE-101 solution for intravenous infusion

Interventions

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ELE-101

ELE-101 solution for intravenous infusion

Intervention Type DRUG

ELE-101 Placebo

ELE-101 placebo matching solution for intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes