Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-01 @ 12:06 PM
Study NCT ID:
NCT07050368
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2025-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers
Sponsor:
MycoMedica Life Sciences PBC
Organization:
Study Overview
Official Title:
A Phase 1 Translational Study to Assess Brain Activity Using Functional Magnetic Resonance Imaging (fMRI) and to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions.
The purpose of this trial is to investigate brain activity, safety, tolerability, and PK of multiple doses of MLS101 in healthy participants.
The purpose of this trial is to investigate brain activity, safety, tolerability, and PK of multiple doses of MLS101 in healthy participants.
Detailed Description:
In recent years, high-dose psilocybin has gained attention for it potential therapeutic benefit in many psychiatric conditions, however existing clinical data for low psilocybin doses are limited.
The multiple-dose regimen proposed in this study is designed to optimize the pharmacology of MLS101 and elucidate whether it provides a longer period of positive effects, which could be used in future studies in chronic indications such as PMDD, obsessive compulsive disorder and opioid use disorder. Translational functional magnetic resonance imaging (fMRI) imaging will confirm the central nervous system (CNS) activity of priming and repeat low-dose psilocybin, which will serve as a computational evaluation of efficacy and complement the cognitive and perceptual scales and questionnaires.
The multiple-dose regimen proposed in this study is designed to optimize the pharmacology of MLS101 and elucidate whether it provides a longer period of positive effects, which could be used in future studies in chronic indications such as PMDD, obsessive compulsive disorder and opioid use disorder. Translational functional magnetic resonance imaging (fMRI) imaging will confirm the central nervous system (CNS) activity of priming and repeat low-dose psilocybin, which will serve as a computational evaluation of efficacy and complement the cognitive and perceptual scales and questionnaires.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: