A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants
This Phase I interventional, randomized, quadruple-blind, placebo-controlled study (planned n=80; ACTUAL 24) will assess safety, tolerability and pharmacokinetics of low-dose psilocybin (MLS101) in healthy adults using SAD and MAD cohorts.
Details
A randomized, double-blind (quadruple-masked), placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) study evaluating safety, tolerability and pharmacokinetics of MLS101 (psilocybin) in healthy volunteers.
SAD: 24 participants in 3 sequential dose cohorts randomized to MLS101 or placebo; additional cohorts of 8 participants may be enrolled to explore more doses. Outcomes include adverse events, vital signs, ECG, laboratory safety and PK parameters; sensorial/psychedelic effects will also be assessed.