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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06326606
Registration number
NCT06326606
Ethics application status
Date submitted
5/03/2024
Date registered
22/03/2024
Date last updated
13/06/2024
Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants
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Scientific title
A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 (Psilocybin) in Healthy Participants
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Secondary ID [1]
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23-MLS101-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Psilocybin
Treatment: Drugs - Placebo
Active comparator: MLS101 - MLS101 capsule(s) administered orally as a once a day dose
Placebo comparator: Placebo - Active treatment matching capsules will be administered orally as a once a day dose
Treatment: Drugs: Psilocybin
Capsule containing active ingredient, psilocybin
Treatment: Drugs: Placebo
Capsule with no active ingredients
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
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Assessment method [1]
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Timepoint [1]
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Screening (Day -60) to end of study visit (Day 8)
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Primary outcome [2]
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Occurrence of clinically significant changes in physical examination, vital signs, ECGs, clinical laboratory tests, the Columbia-Suicide Severity Rating Scale (C-SSRS).
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Assessment method [2]
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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.
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Timepoint [2]
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Screening (Day -60) to end of study visit (Day 8)
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Secondary outcome [1]
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Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)
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Assessment method [1]
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Timepoint [1]
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Day 1 to Day 3 post-dose and end of study visit (Day 8)
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Secondary outcome [2]
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Pharmacokinetics of MLS10: area under the plasma concentration-time curve (AUC)
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Assessment method [2]
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Timepoint [2]
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Day 1 to Day 3 post-dose and end of study visit (Day 8)
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Secondary outcome [3]
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Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (tmax)
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Assessment method [3]
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Timepoint [3]
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Day 1 to Day 3 post-dose and end of study visit (Day 8)
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Secondary outcome [4]
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Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½)
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Assessment method [4]
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Timepoint [4]
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Day 1 to Day 3 post-dose and end of study visit (Day 8)
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Secondary outcome [5]
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Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F)
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Assessment method [5]
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Timepoint [5]
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Day 1 to Day 3 post-dose and end of study visit (Day 8)
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Secondary outcome [6]
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Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F)
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Assessment method [6]
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Timepoint [6]
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Day 1 to Day 3 post-dose and end of study visit (Day 8)
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Secondary outcome [7]
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Sensorial effects of MLS101
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Assessment method [7]
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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.
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Timepoint [7]
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Day 1 post-dose and end of study visit (Day 8)
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Secondary outcome [8]
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Cognitive function
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Assessment method [8]
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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.
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Timepoint [8]
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Pre-dose (Day -1), Day 1 post-dose and end of study visit (Day 8)
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Eligibility
Key inclusion criteria
Key
1. 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.
2. Healthy, in the opinion of the Investigator, based on prior (history of) or current (ongoing) medical and psychiatric screening assessments.
3. Participants with no clinically significant findings on physical examination, laboratory tests, and cardiac assessment.
4. Body mass index (BMI) within the range 18-32 kg/m2, inclusive.
5. Normal blood pressure.
6. Capable of giving signed informed consent which includes the requirements and restrictions as per the approved study protocol.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Prior known exposure to psilocybin within the past 10 years.
2. Prior (history of) or current (ongoing) diagnosis, or first-degree relatives with clinically significant medical or psychiatric condition or disease.
3. History of or presence of cardiovascular disease.
4. Abnormal and clinically significant ECG.
5. History or presence of a neurodegenerative disorder such Alzheimer's disease or Parkinson's disease.
6. Use of medications that have CNS effects or affect performance.
7. Use of medications with serotonergic activity.
8. History or presence of hypersensitivity or idiosyncratic reaction to psilocybin or related compounds.
9. History of substance or alcohol abuse disorder in the last 1 year.
10. 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2024
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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CMAX Clinical Research Pty Ltd - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
MycoMedica Life Sciences PBC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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 psychedelic effects of MLS101 in healthy adult participants.
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Trial website
https://clinicaltrials.gov/study/NCT06326606
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sepehr Shakib
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Address
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Principal Investigator at CMAX Clinical Research Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ken Colley, MD, PhD
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Address
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Country
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Phone
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+1 415 225 5771
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06326606
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