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 evaluate the safety, tolerability, and pharmacokinetics of multiple doses of MLS101 (a low-dose psilocybin formulation) in healthy adult participants.

The study aims to determine how MLS101 is distributed and cleared by the body while assessing its psychedelic effects. Given the limited clinical data on microdoses of psilocybin, this trial seeks to establish a controlled, prospective foundation for understanding their therapeutic potential.

Participants will be randomly assigned to receive either multiple doses of MLS101 or a placebo, administered orally once per day. The study is sponsored by MycoMedica Life Sciences PBC and is being conducted at CMAX Clinical Research in Adelaide, Australia.

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

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.