NCT07050368

A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers

A Phase 1 Translational Study to Assess Brain Activity Using Functional Magnetic Resonance Imaging (fMRI) and to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: MycoMedica Life Sciences PBC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. The purpose of this trial is to investigate brain activity, safety, tolerability, and PK of multiple doses of MLS101 in healthy participants.

Detailed description

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. The multiple-dose regimen proposed in this study is designed to optimize the pharmacology of MLS101 and elucidate whether it provides a longer period of positive effects, which could be used in future studies in chronic indications such as PMDD, obsessive compulsive disorder and opioid use disorder. Translational functional magnetic resonance imaging (fMRI) imaging will confirm the central nervous system (CNS) activity of priming and repeat low-dose psilocybin, which will serve as a computational evaluation of efficacy and complement the cognitive and perceptual scales and questionnaires.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Psilocybin	Capsule containing active ingredient, psilocybin
DRUG	Placebo	Capsule with no active ingredients

Timeline

• Start date: 2025-07-28
• Primary completion: 2026-01-13
• Completion: 2026-01-13
• First posted: 2025-07-03
• Last updated: 2026-02-13

Locations

1 site across 1 country: United Kingdom