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 planned; 16 actual reported) will evaluate the safety, tolerability, and pharmacokinetics of multiple doses of MLS101 (a low-dose psilocybin formulation) in healthy adult participants.
Details
This randomized, double-blind, placebo-controlled, multiple-dose parallel study assesses safety, tolerability and pharmacokinetics of MLS101 (low-dose psilocybin) in healthy adults.
Participants are allocated to MLS101 or matching placebo in two dose cohorts with once-daily oral administration; the study will characterise systemic exposure and sensorial/psychedelic effects at low doses.
Outcomes include adverse events, vital signs, ECG and laboratory safety assessments, and pharmacokinetic measures; healthy volunteers only.