Healthy VolunteerPhase 1NCT07050368
A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers
A Phase 1 study testing Psilocybin in people with Healthy Volunteer, run by MycoMedica Life Sciences PBC at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jul 2025to 13 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Medicines Research (HMR)
London, NW10 7EW
About this study
Official title: A Phase 1 Translational Study to Assess Brain Activity Using Functional Magnetic Resonance Imaging (fMRI) and to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers
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.
Read the detailed description
In recent years, high-dose psilocybin has gained attention for it potential therapeutic benefit in many psychiatric conditions, however existing clinical data for low psilocybin doses are limited.
The multiple-dose regimen proposed in this study is designed to optimize the pharmacology of MLS101 and elucidate whether it provides a longer period of positive effects, which could be used in future studies in chronic indications such as PMDD, obsessive compulsive disorder and opioid use disorder. Translational functional magnetic resonance imaging (fMRI) imaging will confirm the central nervous system (CNS) activity of priming and repeat low-dose psilocybin, which will serve as a computational evaluation of efficacy and complement the cognitive and perceptual scales and questionnaires.
- Conditions
- Healthy Volunteer
- Being tested
- Psilocybin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Capsule containing active ingredient, psilocybin
PlaceboDrug
Capsule with no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| MLS101 | Active comparator | Not described Receives: Drug: Psilocybin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging (fMRI).
Global functional connectivity
Measured: 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.
Measured: Screening (Day -90) to end of study visit (Day 44)
Secondary outcomes (6)
Pharmacokinetics of MLS101: area under the plasma concentration-time curve (AUC)
Blood sample collections
Measured: Day 1 to Day 16
Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)
Blood sample collections
Measured: Day 1 to Day 16
Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½)
Blood sample collections
Measured: Day 1 to Day 16
Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (Tmax)
Blood sample collection
Measured: Day 1 to Day 16
Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F)
Blood sample collections
Measured: Day 1 to Day 16
Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F)
Blood sample collections
Measured: Day 1 to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start28 Jul 2025
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- MycoMedica Life Sciences PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050368
- Sponsor's protocol ID
- 24-MLS101-103
- Status last verified
- Feb 2026
- First submitted
- 16 Jun 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Translational Study to Assess Brain Activity Using Functional Magnetic Resonance Imaging (fMRI) and to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07050368
- Acronym / sponsor ID
- 24-MLS101-103
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MycoMedica Life Sciences PBCIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In recent years, high-dose psilocybin has gained attention for it potential therapeutic benefit in many psychiatric conditions, however existing clinical data for low psilocybin doses are limited.
The multiple-dose regimen proposed in this study is designed to optimize the pharmacology of MLS101 and elucidate whether it provides a longer period of positive effects, which could be used in future studies in chronic indications such as PMDD, obsessive compulsive disorder and opioid use disorder. Translational functional magnetic resonance imaging (fMRI) imaging will confirm the central nervous system (CNS) activity of priming and repeat low-dose psilocybin, which will serve as a computational evaluation of efficacy and complement the cognitive and perceptual scales and questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MLS101 | Active comparator | Drug: Psilocybin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinCapsule containing active ingredient, psilocybin | Drug | MLS101 |
| PlaceboCapsule with no active ingredients | Drug | Placebo |
Primary outcome
Functional magnetic resonance imaging (fMRI).
Time frame: Screening to Day 23
Global functional connectivity
Number and severity of treatment-emergent adverse events (TEAEs)
Time frame: Screening (Day -90) to end of study visit (Day 44)
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.
6 secondary outcomes
Pharmacokinetics of MLS101: area under the plasma concentration-time curve (AUC)
Time frame: Day 1 to Day 16
Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)
Time frame: Day 1 to Day 16
Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½)
Time frame: Day 1 to Day 16
Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (Tmax)
Time frame: Day 1 to Day 16
Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F)
Time frame: Day 1 to Day 16
Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Day 1 to Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin in people with Healthy Volunteer, run by MycoMedica Life Sciences PBC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional magnetic resonance imaging (fMRI). (time frame: Screening to Day 23). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.