protocolSection identificationModule nctId: NCT06326606, orgStudyIdInfo id: 23-MLS101-101, briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: MycoMedica Life Sciences PBC, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized, double-blind, placebo-controlled, single ascending and multiple dose study to assess the safety, tolerability, and pharmacokinetics of MLS101 in healthy participants. The study consists of 2 parts:Part 1 - Single Ascending Dose (SAD): 24 participants will be enrolled in 3 sequential dose cohorts and will be randomized to receive a single dose of MLS101 or placebo. Additional cohorts (comprising 8 participants in each cohort) may be enrolled to explore more doses.Part 2: Multiple Dose study, doses and administration regimens are pending the results from Part 1, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Occurrence of clinically significant changes in physical examination, vital signs, ECGs, clinical laboratory tests, the Columbia-Suicide Severity Rating Scale (C-SSRS)., secondaryOutcomes measure: Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax), secondaryOutcomes measure: Pharmacokinetics of MLS10: area under the plasma concentration-time curve (AUC), secondaryOutcomes measure: Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (tmax), secondaryOutcomes measure: Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½), secondaryOutcomes measure: Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F), secondaryOutcomes measure: Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F), secondaryOutcomes measure: Sensorial effects of MLS101, secondaryOutcomes measure: Cognitive function, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CMAX Clinical Research Pty Ltd, status: RECRUITING, city: Adelaide, state: South Australia, zip: 5000, country: Australia, contacts name: Eloise Spooner, role: CONTACT, phone: +61 8 7088 7900, email: eloise.spooner@cmax.com.au, contacts name: Sepehr Shakib, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.92866, lon: 138.59863, hasResults: False