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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06326606




Registration number
NCT06326606
Ethics application status
Date submitted
5/03/2024
Date registered
22/03/2024
Date last updated
6/05/2024

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants
Scientific title
A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 (Psilocybin) in Healthy Participants
Secondary ID [1] 0 0
23-MLS101-101
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 -60) to end of study visit (Day 8)
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 -60) to end of study visit (Day 8)
Secondary outcome [1] 0 0
Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)
Timepoint [1] 0 0
Day 1 to Day 3 post-dose and end of study visit (Day 8)
Secondary outcome [2] 0 0
Pharmacokinetics of MLS10: area under the plasma concentration-time curve (AUC)
Timepoint [2] 0 0
Day 1 to Day 3 post-dose and end of study visit (Day 8)
Secondary outcome [3] 0 0
Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (tmax)
Timepoint [3] 0 0
Day 1 to Day 3 post-dose and end of study visit (Day 8)
Secondary outcome [4] 0 0
Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½)
Timepoint [4] 0 0
Day 1 to Day 3 post-dose and end of study visit (Day 8)
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 3 post-dose and end of study visit (Day 8)
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 3 post-dose and end of study visit (Day 8)
Secondary outcome [7] 0 0
Sensorial effects of MLS101
Timepoint [7] 0 0
Day 1 post-dose and end of study visit (Day 8)
Secondary outcome [8] 0 0
Cognitive function
Timepoint [8] 0 0
Pre-dose (Day -1), Day 1 post-dose and end of study visit (Day 8)

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.

Key
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 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.

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
16/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - 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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06326606
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sepehr Shakib
Address 0 0
Principal Investigator at CMAX Clinical Research Pty Ltd
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06326606