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

This randomised, quadruple-blind, placebo-controlled trial (n=24) will assess the safety, tolerability, and pharmacokinetics of multiple doses of MLS101 (psilocybin) in healthy participants.

Conducted by MycoMedica Life Sciences PBC, the Phase I study aims to evaluate how MLS101 is distributed and cleared by the body, as well as its potential sensorial effects at low doses. Participants aged 18–65 will be randomly assigned to receive either MLS101 or a placebo, administered orally once daily. The trial consists of two primary cohorts, with the potential addition of a third cohort to explore further dosing.

The primary outcome measures include the incidence and severity of adverse events, changes in physical and psychiatric assessments, and pharmacokinetic parameters such as maximum serum concentration and elimination half-life. The study is being conducted at CMAX Clinical Research in Adelaide, Australia, and is expected to be completed by May 2025.

Trial Details

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.

Trial Number NCT06643637

Data attribution

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