Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT06258720
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2024-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-emergent adverse events (safety and tolerability)', 'timeFrame': 'From Day 1 to Day 140', 'description': 'Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)'}, {'measure': 'Number of participants with anti-drug antibodies', 'timeFrame': 'From Day 1 to Day 140'}, {'measure': 'Cmax: maximum observed plasma concentration of Lu AF82422', 'timeFrame': 'From Day 1 to Day 140'}, {'measure': 'Tmax: time to maximum observed concentration of Lu AF82422', 'timeFrame': 'From Day 1 to Day 140'}, {'measure': 'AUC0-t: area under the concentration-time curve from zero to time t of Lu AF82422', 'timeFrame': 'From Day 1 to Day 140'}, {'measure': 'AUCinf: area under the concentration-time curve from zero to infinity of Lu AF82422', 'timeFrame': 'From Day 1 to Day 140'}, {'measure': 'AUC%extr: percent extrapolated AUC of total AUC0-inf of Lu AF82422', 'timeFrame': 'From Day 1 to Day 140'}, {'measure': 'AUMC0-inf: area under the first moment concentration-time curve from zero to infinity of Lu AF82422', 'timeFrame': 'From Day 1 to Day 140'}, {'measure': 't1/2: apparent terminal elimination half-life of Lu AF82422', 'timeFrame': 'From Day 1 to Day 140'}, {'measure': 'MRT: mean residence time of Lu AF82422', 'timeFrame': 'From Day 1 to Day 140'}, {'measure': 'CL: systemic clearance of Lu AF82422', 'timeFrame': 'From Day 1 to Day 140'}, {'measure': 't1/2eff: effective elimination half-life of Lu AF82422', 'timeFrame': 'From Day 1 to Day 140'}, {'measure': 'Vz: apparent volume of distribution of Lu AF82422', 'timeFrame': 'From Day 1 to Day 140'}, {'measure': 'Vss: steady-state volume of distribution of Lu AF82422', 'timeFrame': 'From Day 1 to Day 140'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Safety', 'Immunogenicity', 'Tolerability', 'Pharmacokinetics'], 'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The main goals of this trial are to learn more about a) the safety and tolerability of Lu AF82422 (any new or worsening medical issues the participants have with treatment), b) the immunogenicity of Lu AF82422 (the potential for the drug to trigger an unwanted immune response), and c) the pharmacokinetic parameters of Lu AF82422 (how the drug is absorbed, distributed, and processed by the body). During the trial, healthy adult Chinese and Caucasian participants will receive a single dose of Lu AF82422, which will be given as an intravenous infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For Chinese participants only: The participant is Chinese, defined as having four Chinese grandparents.\n* For Caucasian participants only: The participant is Caucasian, defined as having four Caucasian grandparents.\n* The participant has a Body Mass Index (BMI) ≥19 and ≤26 kilograms per square meter (kg/m2) at the Screening Visit and at the Baseline Visit.\n* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.\n\nExclusion Criteria:\n\n* The participant has previously been enrolled in this trial.\n* The participant has previously been dosed with Lu AF82422.\n* The participant has participated in a clinical trial \\<30 days prior to the Screening Visit.\n* The participant has taken any investigational medicinal product \\<3 months or \\<5 half-lives of that product, whichever is longer, prior to administration of the IMP.\n* The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.\n\nOther protocol-defined criteria apply.'}, 'identificationModule': {'nctId': 'NCT06258720', 'briefTitle': 'A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Randomized, Open-label, Parallel-group, Single-dose Trial Investigating the Safety, Immunogenicity, Tolerability, and Pharmacokinetic Properties of Lu AF82422 in Healthy Chinese and Caucasian Participants', 'orgStudyIdInfo': {'id': '19728A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lu AF82422 Dose Level 1', 'description': 'Participants will receive a single intravenous (IV) infusion of Lu AF82422', 'interventionNames': ['Drug: Lu AF82422']}, {'type': 'EXPERIMENTAL', 'label': 'Lu AF82422 Dose Level 2', 'description': 'Participants will receive a single IV infusion of Lu AF82422', 'interventionNames': ['Drug: Lu AF82422']}], 'interventions': [{'name': 'Lu AF82422', 'type': 'DRUG', 'description': 'Lu AF82422 solution for intravenous infusion', 'armGroupLabels': ['Lu AF82422 Dose Level 1', 'Lu AF82422 Dose Level 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'H. Lundbeck A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}