Clinical TrialHealthy VolunteersPsilocybinPlaceboCompleted

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants

This Phase I interventional, randomized, quadruple-blind, placebo-controlled study (planned n=80; ACTUAL 24) will assess safety, tolerability and pharmacokinetics of low-dose psilocybin (MLS101) in healthy adults using SAD and MAD cohorts.

Target Enrollment
24 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

A randomized, double-blind (quadruple-masked), placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) study evaluating safety, tolerability and pharmacokinetics of MLS101 (psilocybin) in healthy volunteers.

SAD: 24 participants in 3 sequential dose cohorts randomized to MLS101 or placebo; additional cohorts of 8 participants may be enrolled to explore more doses. Outcomes include adverse events, vital signs, ECG, laboratory safety and PK parameters; sensorial/psychedelic effects will also be assessed.

Study Arms & Interventions

MLS101

experimental

Oral MLS101 (psilocybin) capsules in single-ascending and multiple-ascending dose cohorts

Interventions

  • Psilocybin
    via Oral• once a day

    Single ascending dose (SAD) and multiple ascending dose (MAD) capsule cohorts; marketed as MLS101; no fixed mg dose specified in registry fragment.

Placebo

inactive

Matching placebo capsules

Interventions

  • Placebo
    via Oral• once a day

    Matching placebo capsule.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Key Inclusion Criteria:
  • 1. Males or females aged 18 to 65 years old (inclusive) at the time of signing the informed consent form. Standard contraception measures are required for this clinical trial.
  • 2. Healthy, in the opinion of the Investigator, based on prior (history of) or current (ongoing) medical and psychiatric screening assessments.
  • 3. Participants with no clinically significant findings on physical examination, laboratory tests, and cardiac assessment.
  • 4. Body mass index (BMI) within the range 18-32 kg/m2, inclusive.
  • 5. Normal blood pressure.
  • 6. Capable of giving signed informed consent which includes the requirements and restrictions as per the approved study protocol.

Exclusion Criteria

  • Key Exclusion Criteria:
  • 1. Prior known exposure to psilocybin within the past 10 years.
  • 2. Prior (history of) or current (ongoing) diagnosis, or first-degree relatives with clinically significant medical or psychiatric condition or disease.
  • 3. History of or presence of cardiovascular disease.
  • 4. Abnormal and clinically significant ECG.
  • 5. History or presence of a neurodegenerative disorder such Alzheimer's disease or Parkinson's disease.
  • 6. Use of medications that have CNS effects or affect performance.
  • 7. Use of medications with serotonergic activity.
  • 8. History or presence of hypersensitivity or idiosyncratic reaction to psilocybin or related compounds.
  • 9. History of substance or alcohol abuse disorder in the last 1 year.
  • 10. Participant who, for any reason, is deemed by the Investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2024-03-01
    End: 2024-10-31
  • Compounds
    PsilocybinPlacebo
  • Topic
    Healthy Volunteers

Locations

CMAX Clinical Research Pty Ltd — Adelaide, South Australia, Australia

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