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

Key Inclusion Criteria:

1. Males or females aged 18 to 65 years old (inclusive) at the time of signing theinformed consent form. Standard contraception measures are required for thisclinical 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 andrestrictions 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 withclinically 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 orParkinson'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 orrelated 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 inappropriatefor this study; or has any condition which would confound or interfere with theevaluation of the safety, tolerability, or PK of the investigational drug; or isunable to comply with the study protocol.