A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants

This Phase I intervention trial (n=80) will assess the safety, tolerability, and pharmacokinetics of psilocybin (MLS101 ) in healthy participants.

MLS101 is a low-dose psilocybin being developed for neurological and psychiatric conditions. The trial aims to evaluate the safety, distribution, and clearance of MLS101, as well as its psychedelic effects in healthy adults. Microdoses of psilocybin, which are doses absent of profound sensory and cognitive effects, will be administered to participants in a controlled manner.

The study is designed as a randomized, double-blind, placebo-controlled, single ascending, and multiple-dose study. In the first part, 24 participants will be enrolled in three sequential dose cohorts and receive a single dose of MLS101 or a placebo. The study will also explore additional doses if necessary.

The second part of the study will involve multiple doses, and the doses and administration regimens will depend on the results from the first part.

The trial, conducted by MycoMedica Life Sciences PBC, commenced in March 2024 and is estimated to be completed by October 2024.

Topic Healthy Subjects Safety Neurocognitive Disorders
Compound Psilocybin Placebo
Country Australia
Visit trial
Status Recruiting
Results Published No
Start date 01 March 2024
End date 31 October 2024
Phase Phase I
Design Blinded
Type Interventional
Generation Second
Participants 80
Sex All
Age 18- 65
Therapy No

Trial Details

MLS101 is being developed as a low dose psilocybin, that can be administered to treat various 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.

NCT Number NCT06326606

Data attribution

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