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

NCT06643637 | Completed Phase 1

• 1 other identifier: 24-MLS101-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

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

  Physical examinations, safety laboratory tests, ECGs

  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the ten suicidal ideation and behaviour questions (Categories 1-10) on the C-SSRS) at any time during the study will be withdrawn from the study.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.

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

Secondary Outcomes (10)

• Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)

  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)

  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)

  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: apparent terminal elimination half-life (t½)

  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: apparent total systemic clearance after oral administration (CL/F)

  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)

Study Arms (2)

MLS101

ACTIVE COMPARATOR

MLS101 capsule(s) administered orally as a once a day dose

Drug: Psilocybin

Placebo

PLACEBO COMPARATOR

Active treatment matching capsules will be administered orally as a once a day dose

Drug: Placebo

Interventions

Psilocybin DRUG

Capsule containing active ingredient, psilocybin

Also known as: MLS101

MLS101

Placebo DRUG

Capsule with no active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MycoMedica Life Sciences PBC: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, placebo-controlled multiple dose study to assess the safety, tolerability, and pharmacokinetics of MLS101 in healthy participants. Multiple Dose (MD): 16 participants will be enrolled in two dose cohorts and will be randomized to receive multiple doses of MLS101 or placebo. An additional cohort (8 participants) may enrolled to explore more doses.

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 16, 2024
• Study Start: November 8, 2024
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

AU (1)