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

MycoMedica Life Sciences PBC16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

PsilocybinDRUG

Capsule containing active ingredient, psilocybin

PlaceboDRUG

Capsule with no active ingredients

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 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.

Locations (1)

CMAX Clinical Research

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Incidence, severity and seriousness of treatment-emergent adverse events (TEAEs)

Physical examinations, safety laboratory tests, ECGs

Time frame: Screening (Day -28) to end of study visit (Cohort 1: Day 15; Cohort 2: Day 23)

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.

Time frame: Screening (Day -28) to end of study visit (Cohort 1: Day 15; Cohort 2: Day 23)

Secondary Outcomes

Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)

Blood sample collections

Time frame: 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)

Pharmacokinetics of MLS101: area under the plasma concentration-time curve (AUC)

Blood sample collections

Time frame: 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)

Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (Tmax)

Data from ClinicalTrials.gov

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