A Study to Evaluate the Safety, Tolerability, and... — Clinical Trial Details

A randomized, double-blind (quadruple-masked), placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) study evaluating safety, tolerability and pharmacokinetics of MLS101 (psilocybin) in healthy volunteers.

SAD: 24 participants in 3 sequential dose cohorts randomized to MLS101 or placebo; additional cohorts of 8 participants may be enrolled to explore more doses. Outcomes include adverse events, vital signs, ECG, laboratory safety and PK parameters; sensorial/psychedelic effects will also be assessed.

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.

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.

Company

Product

Legal

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

Detailed Description

Study Arms & Interventions

MLS101

Interventions

Placebo

Interventions

Locations

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators