Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-02-20 @ 4:49 PM
Study NCT ID:
NCT03611569
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2018-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Cohort'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2018-07-26', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)', 'timeFrame': 'From dosing to Day 84', 'description': 'Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)'}], 'secondaryOutcomes': [{'measure': 'AUC 0-t', 'timeFrame': 'From dosing to Day 84', 'description': 'Area under the Lu AF82422 plasma concentration curve from zero to time t'}, {'measure': 'Cmax', 'timeFrame': 'From dosing to Day 84', 'description': 'Maximum observed plasma concentration of Lu AF82422'}, {'measure': 'CL', 'timeFrame': 'From dosing to Day 84', 'description': 'Clearance of Lu AF82422'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate the safety of a single dose of Lu AF82422, how well it is tolerated, how the drug effects the body and what the body does to the drug in healthy non-Japanese and Japanese subjects and in patients with Parkinson's disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\nHealthy subjects:\n\n\\- Men and women ≥18 and ≤55 years of age with a body mass index (BMI) ≥18 and ≤32 kg/m2 (non-Japanese subjects) and ≥18 and ≤28 kg/m2 (Japanese subjects)\n\nPatients with Parkinson's disease:\n\n* Men and women with a clinical diagnosis of idiopathic Parkinson's disease, Hoehn and Yahn (H\\&Y, stage 1-3)\n* For a minimum of three months prior to enrolment, Parkinson's disease symptoms have been stable and is anticipated to be stable during the study duration as judged by the PI\n* If on Parkinson's disease treatment the dose must be stable for a minimum of three months prior to enrolment and is anticipated to be stable during the study duration as judged by the PI\n* ≥40 and ≤80 years of age\n* BMI ≥18 and ≤35 kg/m2\n\nExclusion criteria:\n\n* Atypical Parkinsonism\n* Clinically relevant structural brain abnormality, as assessed using MRI\n* Mild cognitive impairment, measured as a Montreal cognitive assessment (MoCA) score =\\<21\n* Any past or current treatment with an active vaccine targeting alpha-synuclein\n* Any past or current treatment with a monoclonal antibody within the last 12 months\n\nOther in- and exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT03611569', 'briefTitle': "Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': "Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': '17699A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lu AF82422', 'description': "Part A:\n\nCohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women)\n\nPart B:\n\nCohort B1, B2, B3: 24 patients with Parkinson's disease", 'interventionNames': ['Drug: Lu AF82422']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "Part A:\n\nCohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women)\n\nPart B:\n\nCohort B1, B2, B3: 24 patients with Parkinson's disease", 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lu AF82422', 'type': 'DRUG', 'description': 'Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose', 'armGroupLabels': ['Lu AF82422']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo - concentrate for solution for infusion, single dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'California Clinical Trials Medical Group (CCTMG)', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Reserach Center of America', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'PPD', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@Lundbeck.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}