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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 in Healthy Participants

PHASE1NOT_YET_RECRUITING

MLS101 is being developed as a low dose psilocybin, that can be administered to treat 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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Study details:

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. 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 psilocybin microdoses, this study will assess the safety, tolerability, pharmacokinetics and sensorial effects using a prospective, controlled, multiple dose regimen in healthy volunteers.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

Exclusion criteria

Prior known exposure to psilocybin 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 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.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-25

Primary completion: 2025-05-01

Study completion finish: 2025-05-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06643637

Intervention or treatment

DRUG: Psilocybin

DRUG: Placebo

Conditions

• Healthy Volunteers

Condition: Healthy Volunteers
DRUG: Psilocybin and other drugs
Adelaide, South Australia, Australia
Sponsor: MycoMedica Life Sciences PBC

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Find a site

Closest Location:

CMAX Clinical Research

Research sites nearby

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CMAX Clinical Research
Adelaide, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: MLS101 MLS101 capsule(s) administered orally as a once a day dose	DRUG: Psilocybin Capsule containing active ingredient, psilocybin
PLACEBO_COMPARATOR: Placebo Active treatment matching capsules will be administered orally as a once a day dose	DRUG: Placebo Capsule with no active ingredients

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence, severity and seriousness of treatment-emergent adverse events (TEAEs)	Not Specified	Screening (Day -28) to end of study visit (Cohort 1: Day 15; Cohort 2: Day 19)
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 behaviour (a "yes" answer at any time during treatment to any one of the ten suicidal ideation and behaviour 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.	Screening (Day -28) to end of study visit (Cohort 1: Day 15; Cohort 2: Day 19)

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)	Not Specified	Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 12 pre-dose, Day 1 to Day 13 post-dose (Cohort 2)
Pharmacokinetics of MLS101: area under the plasma concentration-time curve (AUC)	Not Specified	Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 12 pre-dose, Day 1 to Day 13 post-dose (Cohort 2)
Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (Tmax)	Not Specified	Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 12 pre-dose, Day 1 to Day 13 post-dose (Cohort 2)
Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½)	Not Specified	Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 12 pre-dose, Day 1 to Day 13 post-dose (Cohort 2)
Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F)	Not Specified	Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 12 pre-dose, Day 1 to Day 13 post-dose (Cohort 2)
Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F)	Not Specified	Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 12 pre-dose, Day 1 to Day 13 post-dose (Cohort 2)
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.	Day 1 to Day 8 pre- and post-dose (Cohort 1); Day 1 to Day 12 pre- and post-dose (Cohort 2)
Cognitive function: Digit Symbol Substitution Test (DSST)	The test taker's score is the number of correct symbol-to-number matches they complete within the allotted time.	Pre-dose (Day -1), Day 1, Day 4 and Day 8 (Cohort 1); Pre-dose (Day -1), Day 1, Day 4 and Day 12 (Cohort 2)
Cognitive Function: Stroop Color and Word Test (SCWT)	Participants read tables of words and colors as quickly as possible.	Pre-dose (Day -1), Day 1, Day 4 and Day 8 (Cohort 1); Pre-dose (Day -1), Day 1, Day 4 and Day 12 (Cohort 2)
Cognitive function: Trail Making Test A (TMT-A)	The participant draws lines to connect circled numbers in an ascending pattern (i.e., in numerical sequence 1-2-3, etc.) as rapidly as possible. The score is the time it takes the participant to complete the task in seconds.	Pre-dose (Day -1), Day 1, Day 4 and Day 8 (Cohort 1); Pre-dose (Day -1), Day 1, Day 4 and Day 12 (Cohort 2)

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References

Clinical Trials Gov: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 in Healthy Participants