A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 in Healthy Participants
NCT ID: NCT06643637
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2024-11-08
2025-03-12
Brief Summary
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The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy, adult participants.
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Detailed Description
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Microdoses are generally considered to be those absent of profound sensory and cognitive effects that would interfere with normal everyday functioning, but only a small number of prospective studies have evaluated microdoses and/or low doses in a controlled manner.
As a foundational study of the therapeutic use of psilocybin microdoses, this study will assess the safety, tolerability, pharmacokinetics and sensorial effects using a prospective, controlled, multiple dose regimen in healthy volunteers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Multiple Dose (MD): 16 participants will be enrolled in two dose cohorts and will be randomized to receive multiple doses of MLS101 or placebo. An additional cohort (8 participants) may enrolled to explore more doses.
TREATMENT
QUADRUPLE
Study Groups
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MLS101
MLS101 capsule(s) administered orally as a once a day dose
Psilocybin
Capsule containing active ingredient, psilocybin
Placebo
Active treatment matching capsules will be administered orally as a once a day dose
Placebo
Capsule with no active ingredients
Interventions
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Psilocybin
Capsule containing active ingredient, psilocybin
Placebo
Capsule with no active ingredients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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MycoMedica Life Sciences PBC
INDUSTRY
Responsible Party
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Locations
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CMAX Clinical Research
Adelaide, South Australia, Australia
Countries
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Other Identifiers
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24-MLS101-102
Identifier Type: -
Identifier Source: org_study_id
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