Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-03-28 @ 3:39 PM
Study NCT ID:
NCT06702332
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2024-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Dose Study of MSD-001 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In Part 1, Participants (n=8) will be randomized to receive either MSD-001 or placebo (6 active: 2 placebo) in each of 5 ascending dose levels (cohorts).\n\nIn Part 2, Participants (n=4) with a CYP2D6 poor metabolizing phenotype will all receive MSD-001 (4 active: 0 placebo) in each of 3 ascending dose levels (cohorts).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-14', 'studyFirstSubmitDate': '2024-11-11', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the safety and tolerability of MSD-001 in healthy adult participants by assessing the number, duration, severity, drug relatedness and type of adverse events', 'timeFrame': 'up to 30 days', 'description': 'Treatment emergent adverse events/ treatment emergent serious adverse events - their frequency, duration and severity, clinically significant changes in lab parameters, ECG, and vital signs'}], 'secondaryOutcomes': [{'measure': 'Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Maximum Plasma Concentration (Cmax)', 'timeFrame': 'Pre-dose and up to 24 hours post dose', 'description': 'Following completion of each cohort, bioanalytical analysis for MSD-001 serial PK timepoints will be performed and plasma PK parameters for Cmax analyzed'}, {'measure': 'Plasma Pharmacokinetics (PK) of a single dose of MSD-001: time to attain Cmax (Tmax)', 'timeFrame': 'Pre-dose and up to 24 hours post dose', 'description': 'Following completion of each cohort, bioanalytical analysis for MSD-001 serial PK will be performed and plasma PK parameters for Tmax analyzed'}, {'measure': 'Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Area under plasma Concentration (AUC)', 'timeFrame': 'Pre-dose and up to 24 hours post dose', 'description': 'Following completion of each cohort, bioanalytical analysis for MSD-001 serial PK timepoints will be performed and plasma PK parameters for AUC analyzed'}, {'measure': 'Plasma Pharmacokinetics (PK) of a single dose of MSD-001: terminal elimination half-life (T1/2)', 'timeFrame': 'Pre-dose and up to 24 hours post dose', 'description': 'Following completion of each cohort, bioanalytical analysis for MSD-001 serial PK will be performed and plasma PK parameters for T1/2 analyzed'}, {'measure': '5D-ASC (5 dimensional altered states of consciousness) rating scale (a 94-item VAS questionnaire)', 'timeFrame': 'Pre-dose and 24 hours post dose', 'description': "Participants will be asked to reflect on the previous days' subjective experience using 5D-ASC rating scale."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase 1 single ascending dose (SAD) study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamic profile of MSD-001 when administered orally to healthy adult participants.', 'detailedDescription': 'This is a first in human, prospective, single center, double blind, placebo-controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MSD-001. The study will include two parallel parts, Part 1 and Part 2, stratified by CYP2D6 phenotype.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Male or female healthy consented participants 18 to 55 years of age\n* CYP2D6 phenotype established based on pharmacogenetic testing.\n* Free from psychoactive drug use from 4 weeks before dosing and until the last follow up visit.\n\nKey Exclusion Criteria:\n\n* Any current clinically relevant, or history of, acute or chronic diseases inclusive of psychiatric disorders and relevant family history, which could interfere with the participant's safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.\n* Moderate to severe congestive heart failure, history of heart surgery, pulmonary hypertension, systemic hypertension (i.e., systolic BP \\>139 mm hg, diastolic blood pressure \\> 89 mm hg), pulse rate \\> 90 bpm, clinically significant ECG abnormality, QTc \\> 450 msec, myocardial infarction in the past year, or any other active or severe cardiovascular condition.\n* Clinically significant personal or familial history of epilepsy, seizures, convulsions, or other seizure disorder (excluding febrile seizures as a child), previous head trauma or other risk factor for seizure.\n* Use of any psychedelic drug in the three months prior to planned dosing or the occurrence of persistent psychological effects following the previous use of psychedelic drugs.\n* Subject experiences severe anticipatory anxiety or is otherwise considered unfit for study.\n* History of moderate or severe illicit substance abuse or dependence, or a positive test result(s) for alcohol and/or drugs of abuse at screening or admission to the clinical unit.\n* Subject has received a prior investigational intervention, has had a history of relevant hypersensitivity or allergic reactions, and has donated and/or received any blood or blood products or experienced blood loss, that may interfere with the objectives of the study.\n* Subject has a significant negative life event (e.g. loss of a loved one) in the past 6 months."}, 'identificationModule': {'nctId': 'NCT06702332', 'briefTitle': 'Single Ascending Dose Study of MSD-001 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mindstate Design Labs'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Sequential, Adaptive Single Ascending Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamic Profile of Orally Administered MSD-001 in Healthy Participants.', 'orgStudyIdInfo': {'id': 'MSD001-NL-001'}, 'secondaryIdInfos': [{'id': '2024-512939-67-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Treatment: MSD-001', 'description': 'Planned doses of MSD-001; N = 42', 'interventionNames': ['Drug: MSD-001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': 'Non-active study drug N = 10', 'interventionNames': ['Drug: Placebo Comparator']}], 'interventions': [{'name': 'MSD-001', 'type': 'DRUG', 'description': 'MSD-001 is being developed as part of future two-agent combination treatment approaches for the management of mental health indications', 'armGroupLabels': ['Active Treatment: MSD-001']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'description': 'Matching Placebo', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Centre for Human Drug Research', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Gabriel Jacobs, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Human Drug Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mindstate Design Labs', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}