Healthy VolunteersPhase 1NCT06326606
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants
A Phase 1 study testing Psilocybin in people with Healthy Volunteers, run by MycoMedica Life Sciences PBC at 1 site in Australia.
Trial summary
MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions. The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- 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
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Mar 2024to 8 Jul 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females aged 18 to 65 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.
- 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 within the past 10 years.
- Prior (history of) or current (ongoing) diagnosis, or first-degree relatives with clinically significant medical or psychiatric condition or disease.
- History of or presence of cardiovascular disease.
- Abnormal and clinically significant ECG.
- History or presence of a neurodegenerative disorder such Alzheimer's disease or Parkinson's disease.
- Use of medications that have CNS effects or affect performance.
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- Use of medications with serotonergic activity.
- History or presence of hypersensitivity or idiosyncratic reaction to psilocybin or related compounds.
- History of substance or alcohol abuse disorder in the last 1 year.
- Participant who, for any reason, is deemed by the Investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
About this study
Official title: A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 (psilocybin) in Healthy Participants
MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions.
The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy adult participants.
Read the detailed description
In recent years, high-dose psilocybin has gained attention for its potential therapeutic benefits in many psychiatric indications, however existing clinical data for low psilocybin doses are limited.
Microdoses are generally considered to be those absent of profound sensory and cognitive effects that would interfere with normal everyday functioning, but only a small number of prospective studies have evaluated microdoses and/or low doses in a controlled manner.
As a foundational study of the therapeutic use of low doses of psilocybin, this study will evaluate the safety, tolerability, pharmacokinetics, and sensorial effects using a prospective, controlled, single ascending dose/multiple ascending doses in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Psilocybin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called MLS101
Capsule containing active ingredient, psilocybin
PlaceboDrug
Capsule with no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| MLS101 | Active comparator | MLS101 capsule(s) administered orally as a once a day dose Receives: Drug: Psilocybin |
| Placebo | Placebo comparator | Active treatment matching capsules will be administered orally as a once a day dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
Measured: Screening (Day -60) to end of study visit (Day 8)
Occurrence of clinically significant changes in physical examination, vital signs, ECGs, clinical laboratory tests, the Columbia-Suicide Severity Rating Scale (C-SSRS).
The Columbia Suicide Severity Rating Scale (C-SSRS) is a short questionnaire. If there is a positive result for suicidality on the C-SSRS after Screening (defined by a participant answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS), the participant will be evaluated by an Investigator or medically qualified Sub-investigator for continuation in the study. Participants with suicidal ideation or behavior (a "yes" answer at any time during treatment to any one of the ten suicidal ideation and behavior questions (Categories 1-10) on the C-SSRS) at any time during the study will be withdrawn from the study. If a participant becomes suicidal during the study, an Investigator or medically qualified Sub-investigator should provide the appropriate treatment to the participant.
Measured: Screening (Day -60) to end of study visit (Day 8)
Secondary outcomes (8)
Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)
Measured: Day 1 to Day 3 post-dose and end of study visit (Day 8)
Pharmacokinetics of MLS10: area under the plasma concentration-time curve (AUC)
Measured: Day 1 to Day 3 post-dose and end of study visit (Day 8)
Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (tmax)
Measured: Day 1 to Day 3 post-dose and end of study visit (Day 8)
Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½)
Measured: Day 1 to Day 3 post-dose and end of study visit (Day 8)
Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F)
Measured: Day 1 to Day 3 post-dose and end of study visit (Day 8)
Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F)
Measured: Day 1 to Day 3 post-dose and end of study visit (Day 8)
Sensorial effects of MLS101
Using validated questionnaires, the nominal sensorial threshold dose of MLS101 will be identified. The nominal sensorial threshold dose is defined as the highest dose studied that is absent of clinically significant sensorial effects, and which would not interfere with the participant's ability to carry on with routine activities of daily living. Higher scores indicate presence of sensorial effects.
Measured: Day 1 post-dose and end of study visit (Day 8)
Cognitive function
Using validated questionnaires and tools, cognitive function will be assessed and scores will be summarized for each visit, including observed values and change from baseline to evaluate the effects of MLS101 on participants' cognitive function.
Measured: Pre-dose (Day -1), Day 1 post-dose and end of study visit (Day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start27 Mar 2024
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Model description
- This is a randomized, double-blind, placebo-controlled, single ascending and multiple dose study to assess the safety, tolerability, and pharmacokinetics of MLS101 in healthy participants. Single Ascending Dose (SAD): 24 participants will be enrolled in 3 sequential dose cohorts and will be randomized to receive a single dose of MLS101 or placebo. Additional cohorts (comprising 8 participants in each cohort) may be enrolled to explore more doses.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- MycoMedica Life Sciences PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sepehr Shakib, Principal investigator, Principal Investigator at CMAX Clinical Research Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326606
- Sponsor's protocol ID
- 23-MLS101-101
- Status last verified
- Oct 2024
- First submitted
- 5 Mar 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 (psilocybin) in Healthy Participants
- ClinicalTrials.gov ID
- NCT06326606
- Acronym / sponsor ID
- 23-MLS101-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- MycoMedica Life Sciences PBCIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 22 Mar 2024 (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 various neurological and psychiatric conditions.
The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy adult participants.
Detailed description
In recent years, high-dose psilocybin has gained attention for its potential therapeutic benefits in many psychiatric indications, however existing clinical data for low psilocybin doses are limited.
Microdoses are generally considered to be those absent of profound sensory and cognitive effects that would interfere with normal everyday functioning, but only a small number of prospective studies have evaluated microdoses and/or low doses in a controlled manner.
As a foundational study of the therapeutic use of low doses of psilocybin, this study will evaluate the safety, tolerability, pharmacokinetics, and sensorial effects using a prospective, controlled, single ascending dose/multiple ascending doses in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled, single ascending and multiple dose study to assess the safety, tolerability, and pharmacokinetics of MLS101 in healthy participants. Single Ascending Dose (SAD): 24 participants will be enrolled in 3 sequential dose cohorts and will be randomized to receive a single dose of MLS101 or placebo. Additional cohorts (comprising 8 participants in each cohort) may be enrolled to explore more doses.
| Arm | Type | Receives |
|---|---|---|
| MLS101 | Active comparator | Drug: PsilocybinMLS101 capsule(s) administered orally as a once a day dose |
| Placebo | Placebo comparator | Drug: PlaceboActive treatment matching capsules will be administered orally as a once a day dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females aged 18 to 65 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.
Key exclusion criteria (10 listed)
- Prior known exposure to psilocybin within the past 10 years.
- Prior (history of) or current (ongoing) diagnosis, or first-degree relatives with clinically significant medical or psychiatric condition or disease.
- History of or presence of cardiovascular disease.
- Abnormal and clinically significant ECG.
- History or presence of a neurodegenerative disorder such Alzheimer's disease or Parkinson's disease.
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 |
|---|---|---|
| PsilocybinAlso: MLS101Capsule containing active ingredient, psilocybin | Drug | MLS101 |
| PlaceboCapsule with no active ingredients | Drug | Placebo |
Primary outcome
Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
Time frame: Screening (Day -60) to end of study visit (Day 8)
Occurrence of clinically significant changes in physical examination, vital signs, ECGs, clinical laboratory tests, the Columbia-Suicide Severity Rating Scale (C-SSRS).
Time frame: Screening (Day -60) to end of study visit (Day 8)
The Columbia Suicide Severity Rating Scale (C-SSRS) is a short questionnaire. If there is a positive result for suicidality on the C-SSRS after Screening (defined by a participant answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS), the participant will be evaluated by an Investigator or medically qualified Sub-investigator for continuation in the study. Participants with suicidal ideation or behavior (a "yes" answer at any time during treatment to any one of the ten suicidal ideation and behavior questions (Categories 1-10) on the C-SSRS) at any time during the study will be withdrawn from the study. If a participant becomes suicidal during the study, an Investigator or medically qualified Sub-investigator should provide the appropriate treatment to the participant.
8 secondary outcomes
Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)
Time frame: Day 1 to Day 3 post-dose and end of study visit (Day 8)
Pharmacokinetics of MLS10: area under the plasma concentration-time curve (AUC)
Time frame: Day 1 to Day 3 post-dose and end of study visit (Day 8)
Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (tmax)
Time frame: Day 1 to Day 3 post-dose and end of study visit (Day 8)
Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½)
Time frame: Day 1 to Day 3 post-dose and end of study visit (Day 8)
Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F)
Time frame: Day 1 to Day 3 post-dose and end of study visit (Day 8)
Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Day 1 to Day 3 post-dose and end of study visit (Day 8)
Sensorial effects of MLS101
Time frame: Day 1 post-dose and end of study visit (Day 8)
Cognitive function
Time frame: Pre-dose (Day -1), Day 1 post-dose and end of study visit (Day 8)
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 9 Oct 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Sepehr Shakib principal investigator
Principal Investigator at CMAX Clinical Research Pty Ltd
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 Volunteers, run by MycoMedica Life Sciences PBC at 1 site in Australia.
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 6 inclusion and 10 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 9 Oct 2024. 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 Australia. 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?
Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) (time frame: Screening (Day -60) to end of study visit (Day 8)). 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 9 Oct 2024.