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

NCT07050368 | Completed Phase 1

• 1 other identifier: 24-MLS101-103
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Functional magnetic resonance imaging (fMRI).

  Global functional connectivity

  Screening to Day 23

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

  An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent adverse event (TEAE) if the onset date and time is at the time of or after first study drug administration.

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

Secondary Outcomes (6)

• Pharmacokinetics of MLS101: area under the plasma concentration-time curve (AUC)

  Day 1 to Day 16

• Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)

  Day 1 to Day 16

• Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½)

  Day 1 to Day 16

• Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (Tmax)

  Day 1 to Day 16

• Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F)

  Day 1 to Day 16

Other Outcomes (5)

• Perceptual effects of MLS101 using Mystical Experience Questionnaire (MEQ30) score and change from baseline score.

  Day 1 to Day 16

• Perceptual effects of MLS101 using 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) score and change from baseline score.

  Day 1 to Day 16

• Perceptual effects of MLS101 using the Acute Subjective Effects Scale (ASES) score and change from baseline score.

  Day 1 to Day 16

Study Arms (2)

MLS101

ACTIVE COMPARATOR

Drug: Psilocybin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Psilocybin DRUG

Capsule containing active ingredient, psilocybin

MLS101

Placebo DRUG

Capsule with no active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MycoMedica Life Sciences PBC: lead

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 3, 2025
• Study Start: July 28, 2025
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

GB (1)