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.
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.
MLS101 low-dose psilocybin capsules administered once daily in a multiple-dose, parallel design.
MLS101 (low-dose psilocybin) capsule; multiple daily doses in two dose cohorts; mg not specified in registry.
Matching placebo capsules administered once daily.
Matching placebo capsule.