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.

Topic Healthy Subjects Safety
Compound Psilocybin
Country Australia
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