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CompletedPhase 1

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

NCT06643637 · MycoMedica Life Sciences PBC

Closed to entry
Status
Not accepting participants
Phase 1
Phase
16
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. 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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Incidence, severity and seriousness of treatment-emergent adverse events (TEAEs)

    Measured over Screening (Day -28) to end of study visit (Cohort 1: Day 15; Cohort 2: Day 23)

  • Occurrence of clinically significant changes in physical examination, vital signs, ECGs, clinical laboratory tests, the Columbia-Suicide Severity Rating Scale (C-SSRS).

    Measured over Screening (Day -28) to end of study visit (Cohort 1: Day 15; Cohort 2: Day 23)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
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: 1. Prior known exposure to psilocybin within the past 5 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.

Where

1 study site

FacilityCityRegionCountry
CMAX Clinical ResearchAdelaideSouth AustraliaAustralia

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06643637 on ClinicalTrials.gov →

Last updated in the registry 2025-06-12. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits