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

Eleusis Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Major Depressive Disorder; Healthy Volunteers; Depression

Treatments: Drug: ELE-101; Drug: ELE-101 Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05434156

ET1001-ELE-101

2022-000150-29 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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84 participants in 6 patient groups

Cohort 1 (Part 1)

Experimental group

Description:

A single 10-minute intravenous infusion of 0.25 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)

Treatment:

Drug: ELE-101 Placebo

Drug: ELE-101

Cohort 2 (Part 1)

Experimental group

Description:

A single 10-minute intravenous infusion of 0.75 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)

Treatment:

Drug: ELE-101 Placebo

Drug: ELE-101

Cohort 3 (Part 1)

Experimental group

Description:

A single 10-minute intravenous infusion of 2.0 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)

Treatment:

Drug: ELE-101 Placebo

Drug: ELE-101

Cohort 4 (Part 1)

Experimental group

Description:

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

Treatment:

Drug: ELE-101 Placebo

Drug: ELE-101

Cohort 5 (Part 1)

Experimental group

Description:

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

Treatment:

Drug: ELE-101 Placebo

Drug: ELE-101

Cohort 6 (Part 2)

Experimental group

Description:

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

Treatment:

Drug: ELE-101