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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06643637




Registration number
NCT06643637
Ethics application status
Date submitted
10/10/2024
Date registered
16/10/2024
Date last updated
12/12/2024

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 in Healthy Participants
Scientific title
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 (Psilocybin) in Healthy Participants
Secondary ID [1] 0 0
24-MLS101-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence, severity and seriousness of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Screening (Day -28) to end of study visit (Cohort 1: Day 15; Cohort 2: Day 23)
Primary outcome [2] 0 0
Occurrence of clinically significant changes in physical examination, vital signs, ECGs, clinical laboratory tests, the Columbia-Suicide Severity Rating Scale (C-SSRS).
Timepoint [2] 0 0
Screening (Day -28) to end of study visit (Cohort 1: Day 15; Cohort 2: Day 23)
Secondary outcome [1] 0 0
Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)
Timepoint [1] 0 0
Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 16 pre-dose, Day 1 to Day 17 post-dose (Cohort 2)
Secondary outcome [2] 0 0
Pharmacokinetics of MLS101: area under the plasma concentration-time curve (AUC)
Timepoint [2] 0 0
Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 16 pre-dose, Day 1 to Day 17 post-dose (Cohort 2)
Secondary outcome [3] 0 0
Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (Tmax)
Timepoint [3] 0 0
Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 16 pre-dose, Day 1 to Day 17 post-dose (Cohort 2)
Secondary outcome [4] 0 0
Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½)
Timepoint [4] 0 0
Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 16 pre-dose, Day 1 to Day 17 post-dose (Cohort 2)
Secondary outcome [5] 0 0
Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F)
Timepoint [5] 0 0
Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 16 pre-dose, Day 1 to Day 17 post-dose (Cohort 2)
Secondary outcome [6] 0 0
Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F)
Timepoint [6] 0 0
Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 16 pre-dose, Day 1 to Day 17 post-dose (Cohort 2)
Secondary outcome [7] 0 0
Sensorial effects of MLS101
Timepoint [7] 0 0
Day 1 to Day 8 pre- and post-dose (Cohort 1); Day 1 to Day 16 pre- and post-dose (Cohort 2)
Secondary outcome [8] 0 0
Cognitive function: Digit Symbol Substitution Test (DSST)
Timepoint [8] 0 0
Pre-dose (Day -1), Day 1, Day 4 and Day 8 (Cohort 1); Pre-dose (Day -1), Day 1, Day 4 and Day 16 (Cohort 2)
Secondary outcome [9] 0 0
Cognitive Function: Stroop Color and Word Test (SCWT)
Timepoint [9] 0 0
Pre-dose (Day -1), Day 1, Day 4 and Day 8 (Cohort 1); Pre-dose (Day -1), Day 1, Day 4 and Day 16 (Cohort 2)
Secondary outcome [10] 0 0
Cognitive function: Trail Making Test A (TMT-A)
Timepoint [10] 0 0
Pre-dose (Day -1), Day 1, Day 4 and Day 8 (Cohort 1); Pre-dose (Day -1), Day 1, Day 4 and Day 16 (Cohort 2)

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Prior known exposure to psilocybin within the past 5 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MycoMedica Life Sciences PBC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ken Colley, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+1 415 225 5771
Fax 0 0
Email 0 0
kcolley@mycomedica.com
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/NCT06643637