Clinical TrialHealthy VolunteersPsilocybinPlaceboCompleted

A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers

This Phase I randomised, single-blind trial (n=20) will study the effects of multiple low doses of psilocybin (MLS101) on brain activity, safety, tolerability, and pharmacokinetics in healthy adult volunteers.

Target Enrollment
20 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

Phase I, randomised, single-blind parallel study in healthy volunteers using multiple low oral doses of MLS101 (psilocybin) to assess CNS activity with fMRI alongside safety, tolerability and PK.

Outcomes include translational fMRI measures of brain response to priming and repeat low doses, cognitive and perceptual scales, and standard safety assessments (vitals, ECG, labs). Dosing schedule is multiple low-dose capsules (MLS101) versus matching placebo per protocol.

Study Arms & Interventions

MLS101

experimental

Capsule containing active psilocybin (MLS101); multiple low-dose regimen.

Interventions

  • Psilocybin
    via Oral• multiple doses

    Capsule formulation (MLS101); dosing schedule per protocol.

Placebo

inactive

Placebo capsule with no active ingredient.

Interventions

  • Placebo
    via Oral• multiple doses

    Matching placebo capsule.

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • Males or females aged 18 to 55 years old (inclusive) at the time of signing the informed consent form.
  • Standard contraception measures are required for this clinical trial.
  • Healthy, in the opinion of the Investigator, based on prior (history of) or current (ongoing) medical and psychiatric screening assessments.
  • Participants with no clinically significant findings on physical examination, laboratory tests, and cardiac assessment.
  • Body mass index (BMI) within the range 18-32 kg/m2, inclusive.
  • Normal blood pressure.
  • Willing to not operate heavy machinery, including driving a vehicle at least 36 hours post Day 1 dose administration and 24 hours post all other dose administrations.
  • Capable of giving signed informed consent which includes the requirements and restrictions as per the approved study protocol

Exclusion Criteria

  • Prior known exposure to psilocybin, LSD, ayahuasca, N, N-Dimethyltryptamine, and related tryptamines, within the past 5 years.
  • Prior (history of) or current (ongoing) diagnosis, or first-degree relatives with clinically significant medical or psychiatric condition or disease.
  • History of non-hospitalized but medicated Major Depressive Disorder (MDD), Generalized Anxiety Disorder or Panic Disorder ≤ 5 years prior to Screening.
  • History of or presence of cardiovascular disease.
  • Abnormal and clinically significant ECG.
  • Known personal or family history of congenital long QT syndrome or sudden death.
  • Current or a history of orthostatic hypotension or postural orthostatic tachycardic syndrome, multiple syncopes, or unresolved/ongoing clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness.
  • History or presence of a neurodegenerative disorder such Alzheimer's disease or Parkinson's disease or other behavioral disturbances resulting from other neurological disorders.
  • Use of medications that have CNS effects or affect performance.
  • Use of medications with serotonergic activity.
  • History or presence of hypersensitivity or idiosyncratic reaction to psilocybin or related compounds or microcrystalline cellulose.
  • History of substance or alcohol abuse disorder in the last 10 years.
  • Participant who, for any reason, is deemed by the Investigator to be inappropriate for this study.
  • Contraindications to magnetic resonance imaging (MRI) or fMRI.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment20 participants
  • Timeline
    Start: 2025-07-01
    End: 2026-02-01
  • Compounds
    PsilocybinPlacebo
  • Topic
    Healthy Volunteers

Locations

Hammersmith Medicines Research (HMR) — London, United Kingdom

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