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CompletedPhase 1

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

NCT07050368 · MycoMedica Life Sciences PBC

Closed to entry
Status
Not accepting participants
Phase 1
Phase
20
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 trial is to investigate brain activity, safety, tolerability, and PK of multiple doses of MLS101 in healthy 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

  • Functional magnetic resonance imaging (fMRI).

    Measured over Screening to Day 23

  • Number and severity of treatment-emergent adverse events (TEAEs)

    Measured over Screening (Day -90) to end of study visit (Day 44)

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 55 Years
Ages
All
Sex
Accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Hammersmith Medicines Research (HMR)LondonUnited Kingdom

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.

NCT07050368 on ClinicalTrials.gov →

Last updated in the registry 2026-02-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits