Clinical TrialHealthy VolunteersPsilocybinPlaceboCompleted

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

This randomised, quadruple-blind, placebo-controlled trial (n=24 planned; 16 actual reported) will evaluate the safety, tolerability, and pharmacokinetics of multiple doses of MLS101 (a low-dose psilocybin formulation) in healthy adult participants.

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

Detailed Description

This randomized, double-blind, placebo-controlled, multiple-dose parallel study assesses safety, tolerability and pharmacokinetics of MLS101 (low-dose psilocybin) in healthy adults.

Participants are allocated to MLS101 or matching placebo in two dose cohorts with once-daily oral administration; the study will characterise systemic exposure and sensorial/psychedelic effects at low doses.

Outcomes include adverse events, vital signs, ECG and laboratory safety assessments, and pharmacokinetic measures; healthy volunteers only.

Study Arms & Interventions

MLS101

experimental

MLS101 low-dose psilocybin capsules administered once daily in a multiple-dose, parallel design.

Interventions

  • Psilocybin
    via Oral• once daily

    MLS101 (low-dose psilocybin) capsule; multiple daily doses in two dose cohorts; mg not specified in registry.

Placebo

inactive

Matching placebo capsules administered once daily.

Interventions

  • Placebo
    via Oral• once daily

    Matching placebo capsule.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n\n1. 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.\n2. Healthy, in the opinion of the Investigator, based on prior (history of) or current (ongoing) medical and psychiatric screening assessments.\n3. Participants with no clinically significant findings on physical examination, laboratory tests, and cardiac assessment.\n4. Body mass index (BMI) within the range 18-32 kg/m2, inclusive.\n5. Normal blood pressure.\n6. Capable of giving signed informed consent which includes the requirements and restrictions as per the approved study protocol.

Exclusion Criteria

  • Exclusion Criteria:\n\n1. Prior known exposure to psilocybin within the past 5 years.\n2. Prior (history of) or current (ongoing) diagnosis, or first-degree relatives with clinically significant medical or psychiatric condition or disease.\n3. History of or presence of cardiovascular disease.\n4. Abnormal and clinically significant ECG.\n5. History or presence of a neurodegenerative disorder such Alzheimer's disease or Parkinson's disease.\n6. Use of medications that have CNS effects or affect performance.\n7. Use of medications with serotonergic activity.\n8. History or presence of hypersensitivity or idiosyncratic reaction to psilocybin or related compounds.\n9. History of substance or alcohol abuse disorder in the last 1 year.\n10. 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 Enrollment16 participants
  • Timeline
    Start: 2024-11-08
    End: 2025-05-01
  • Compounds
    PsilocybinPlacebo
  • Topic
    Healthy Volunteers

Locations

CMAX Clinical Research — Adelaide, South Australia, Australia

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