Clinical TrialMajor Depressive Disorder (MDD)PsilocybinPlaceboPsilocybinPlaceboPsilocybinPlaceboPsilocybinPlaceboPsilocybinPlaceboPsilocybinActive not recruiting

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

Phase I/II, randomized, triple-blind, placebo-controlled ascending-dose IV study (Part 1, HVs) and Phase IIa open-label IV study in MDD (Part 2); single IV doses of ELE-101 (psilocybin) with PK/PD and safety assessment.

Target Enrollment
84 participants
Study Type
Phase I/II interventional
Design
Randomized, triple Blind

Detailed Description

Part 1 is a randomised, triple-masked, single-ascending-dose IV study in healthy adults evaluating safety, tolerability, PK, PD and subjective drug intensity of ELE-101 (psilocybin) versus placebo across multiple cohorts (0.25 mg, 0.75 mg, 2.0 mg; further doses TBD).

Part 2 is an open-label Phase IIa cohort of patients with major depressive disorder receiving a single IV dose of ELE-101 to evaluate pharmacodynamic effects and safety; key outcomes include adverse events, vital signs, PK parameters and patient-reported subjective intensity.

Study Protocol

Preparation

sessions

Dosing

1 sessions
10 min each

Integration

sessions

Study Arms & Interventions

Cohort 1 (Part 1)

experimental

Single 10-minute IV infusion of ELE-101 0.25 mg or matching placebo (6 active, 2 placebo).

Interventions

  • Psilocybin0.25 mg
    via IV• single dose• 1 doses total
  • Placebo
    via IV• single dose• 1 doses total

    Matching placebo infusion

Cohort 2 (Part 1)

experimental

Single 10-minute IV infusion of ELE-101 0.75 mg or matching placebo (6 active, 2 placebo).

Interventions

  • Psilocybin0.75 mg
    via IV• single dose• 1 doses total
  • Placebo
    via IV• single dose• 1 doses total

    Matching placebo infusion

Cohort 3 (Part 1)

experimental

Single 10-minute IV infusion of ELE-101 2.0 mg or matching placebo (6 active, 2 placebo).

Interventions

  • Psilocybin2 mg
    via IV• single dose• 1 doses total
  • Placebo
    via IV• single dose• 1 doses total

    Matching placebo infusion

Cohort 4 (Part 1)

experimental

Single IV infusion of ELE-101 (dose and infusion duration TBD) or matching placebo (6 active, 2 placebo).

Interventions

  • Psilocybin
    via IV• single dose

    Dose and infusion duration TBD

  • Placebo
    via IV• single dose

    Matching placebo infusion; details TBD

Cohort 5 (Part 1)

experimental

Single IV infusion of ELE-101 (dose and infusion duration TBD) or matching placebo (6 active, 2 placebo).

Interventions

  • Psilocybin
    via IV• single dose

    Dose and infusion duration TBD

  • Placebo
    via IV• single dose

    Matching placebo infusion; details TBD

Cohort 6 (Part 2)

experimental

Open-label single IV infusion of ELE-101 in patients with MDD (dose TBD).

Interventions

  • Psilocybin
    via IV• single dose

    Open-label; dose TBD

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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 Details

Locations

MAC Clinical Research — Liverpool, United Kingdom
MAC Clinical Research — Manchester, United Kingdom

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