Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT06326606
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2024-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011562', 'term': 'Psilocybin'}], 'ancestors': [{'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', '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.\n\nSingle 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Screening (Day -60) to end of study visit (Day 8)'}, {'measure': 'Occurrence of clinically significant changes in physical examination, vital signs, ECGs, clinical laboratory tests, the Columbia-Suicide Severity Rating Scale (C-SSRS).', 'timeFrame': 'Screening (Day -60) to end of study visit (Day 8)', 'description': 'The Columbia Suicide Severity Rating Scale (C-SSRS) is a short questionnaire. If there is a positive result for suicidality on the C-SSRS after Screening (defined by a participant answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS), the participant will be evaluated by an Investigator or medically qualified Sub-investigator for continuation in the study. Participants with suicidal ideation or behavior (a "yes" answer at any time during treatment to any one of the ten suicidal ideation and behavior questions (Categories 1-10) on the C-SSRS) at any time during the study will be withdrawn from the study. If a participant becomes suicidal during the study, an Investigator or medically qualified Sub-investigator should provide the appropriate treatment to the participant.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax)', 'timeFrame': 'Day 1 to Day 3 post-dose and end of study visit (Day 8)'}, {'measure': 'Pharmacokinetics of MLS10: area under the plasma concentration-time curve (AUC)', 'timeFrame': 'Day 1 to Day 3 post-dose and end of study visit (Day 8)'}, {'measure': 'Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (tmax)', 'timeFrame': 'Day 1 to Day 3 post-dose and end of study visit (Day 8)'}, {'measure': 'Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½)', 'timeFrame': 'Day 1 to Day 3 post-dose and end of study visit (Day 8)'}, {'measure': 'Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F)', 'timeFrame': 'Day 1 to Day 3 post-dose and end of study visit (Day 8)'}, {'measure': 'Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F)', 'timeFrame': 'Day 1 to Day 3 post-dose and end of study visit (Day 8)'}, {'measure': 'Sensorial effects of MLS101', 'timeFrame': 'Day 1 post-dose and end of study visit (Day 8)', 'description': "Using validated questionnaires, the nominal sensorial threshold dose of MLS101 will be identified. The nominal sensorial threshold dose is defined as the highest dose studied that is absent of clinically significant sensorial effects, and which would not interfere with the participant's ability to carry on with routine activities of daily living. Higher scores indicate presence of sensorial effects."}, {'measure': 'Cognitive function', 'timeFrame': 'Pre-dose (Day -1), Day 1 post-dose and end of study visit (Day 8)', 'description': "Using validated questionnaires and tools, cognitive function will be assessed and scores will be summarized for each visit, including observed values and change from baseline to evaluate the effects of MLS101 on participants' cognitive function."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions.\n\nThe 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.', 'detailedDescription': 'In recent years, high-dose psilocybin has gained attention for its potential therapeutic benefits in many psychiatric indications, however existing clinical data for low psilocybin doses are limited.\n\nMicrodoses 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 and/or low doses in a controlled manner.\n\nAs a foundational study of the therapeutic use of low doses of psilocybin, this study will evaluate the safety, tolerability, pharmacokinetics, and sensorial effects using a prospective, controlled, single ascending dose/multiple ascending doses in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Males or females aged 18 to 65 years old (inclusive) at the time of signing the informed consent form. Standard contraception measures are required for this clinical trial.\n2. Healthy, in the opinion of the Investigator, based on prior (history of) or current (ongoing) medical and psychiatric screening assessments.\n3. Participants with no clinically significant findings on physical examination, laboratory tests, and cardiac assessment.\n4. Body mass index (BMI) within the range 18-32 kg/m2, inclusive.\n5. Normal blood pressure.\n6. Capable of giving signed informed consent which includes the requirements and restrictions as per the approved study protocol.\n\nKey Exclusion Criteria:\n\n1. Prior known exposure to psilocybin within the past 10 years.\n2. Prior (history of) or current (ongoing) diagnosis, or first-degree relatives with clinically significant medical or psychiatric condition or disease.\n3. History of or presence of cardiovascular disease.\n4. Abnormal and clinically significant ECG.\n5. History or presence of a neurodegenerative disorder such Alzheimer's disease or Parkinson's disease.\n6. Use of medications that have CNS effects or affect performance.\n7. Use of medications with serotonergic activity.\n8. History or presence of hypersensitivity or idiosyncratic reaction to psilocybin or related compounds.\n9. History of substance or alcohol abuse disorder in the last 1 year.\n10. Participant who, for any reason, is deemed by the Investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol."}, 'identificationModule': {'nctId': 'NCT06326606', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'MycoMedica Life Sciences PBC'}, 'officialTitle': 'A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 (psilocybin) in Healthy Participants', 'orgStudyIdInfo': {'id': '23-MLS101-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MLS101', 'description': 'MLS101 capsule(s) administered orally as a once a day dose', 'interventionNames': ['Drug: Psilocybin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Active treatment matching capsules will be administered orally as a once a day dose', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Psilocybin', 'type': 'DRUG', 'otherNames': ['MLS101'], 'description': 'Capsule containing active ingredient, psilocybin', 'armGroupLabels': ['MLS101']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule with no active ingredients', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'CMAX Clinical Research Pty Ltd', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Sepehr Shakib', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator at CMAX Clinical Research Pty Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MycoMedica Life Sciences PBC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}