Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643637
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
A Study to Evaluate the Safety Tolerability and Pharmacokinetics of Multiple Doses of MLS101 in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety Tolerability and Pharmacokinetics of Multiple Doses of MLS101 Psilocybin in Healthy Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 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
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
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
Microdoses are generally considered to be those absent of profound sensory and cognitive effects that would interfere with normal everyday functioning but only a small number of prospective studies have evaluated microdoses andor low doses in a controlled manner
As a foundational study of the therapeutic use of psilocybin microdoses this study will assess the safety tolerability pharmacokinetics and sensorial effects using a prospective controlled multiple dose regimen in healthy volunteers
Microdoses are generally considered to be those absent of profound sensory and cognitive effects that would interfere with normal everyday functioning but only a small number of prospective studies have evaluated microdoses andor low doses in a controlled manner
As a foundational study of the therapeutic use of psilocybin microdoses this study will assess the safety tolerability pharmacokinetics and sensorial effects using a prospective controlled multiple dose regimen in healthy volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None