Psilocybin brain scan study aims to unlock new treatments
NCT ID NCT07050368
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 1 trial tested multiple doses of MLS101, a low-dose psilocybin capsule, in 20 healthy volunteers. Researchers used brain scans (fMRI) to see how the drug affects brain activity, while also checking safety and how the body processes the drug. The goal is to gather information that could support future treatments for neurological and psychiatric conditions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Psilocybin
- What this could lead to
- If successful, this study could help develop low-dose psilocybin as a treatment for neurological and psychiatric conditions.
- What could go wrong
- This is an early-phase trial in only 20 healthy people, so results may not apply to patients. Side effects are possible, and the drug may not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Jul 2025
- Finished
-
Jan 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hammersmith Medicines Research (HMR)
London, NW10 7EW, United Kingdom
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