A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple D… (NCT07050368) | Clinical Trial Compass
CompletedPhase 1
A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers
United Kingdom20 participantsStarted 2025-07-28
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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 …
What they're measuring
1
Functional magnetic resonance imaging (fMRI).
Timeframe: Screening to Day 23
2
Number and severity of treatment-emergent adverse events (TEAEs)
Timeframe: Screening (Day -90) to end of study visit (Day 44)