Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-28 @ 11:46 PM
Study NCT ID:
NCT06336005
Status:
COMPLETED
Last Update Posted:
2025-04-16
First Post:
2024-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy People
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'], 'maskingDescription': 'Sponsor staff involved in the clinical trial is masked according to company standard procedures.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment emergent adverse events (TEAE)', 'timeFrame': 'From time of dosing (Day 1) to end of study (Day 14)', 'description': 'Number of events'}], 'secondaryOutcomes': [{'measure': 'AUC0-t, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose', 'timeFrame': 'From pre-dose (Day 1) to end of exposure (Day 7)', 'description': 'Hours\\*micrometer (hr×µM)'}, {'measure': 'AUC0-∞, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose', 'timeFrame': 'From pre-dose (Day 1) to end of exposure (Day 7)', 'description': 'Hours\\*micrometer (hr×µM)'}, {'measure': 'Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose', 'timeFrame': 'From pre-dose (Day 1) to end of exposure (Day 7)', 'description': 'Micrometer (µM)'}, {'measure': 'IL-1β, SD; ratio of <Timepoint> (time of the maximal plasma concentration of NNC6022 0001) to baseline', 'timeFrame': 'From pre-dose (Day 1) to estimated tmax (Day 1)', 'description': 'Percentage (%)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'Cardiometabolic Diseases']}, 'descriptionModule': {'briefSummary': 'The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases.\n\nThe aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine.\n\nParticipants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.\n\nThe study will last for about 10 months in total.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men or women of non-childbearing potential.\n2. Age 18-55 years (both inclusive) at the time of signing the informed consent.\n3. Body mass index (BMI) between 18.5 to 29.9 kg/m\\^2 (both inclusive) at screening.\n4. Body Weight: Greater than or equal to 50 kg at screening.\n5. Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n\nExclusion Criteria:\n\n1. Known or suspected hypersensitivity to study intervention(s) or similar products.\n2. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n3. Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values:.\n\n * Alanine Aminotransferase (ALT) above upper normal limit (UNL)\n * Aspartate aminotransferase (AST) above UNL\n * Total Bilirubin (BL) above UNL\n * Creatinine above UNL\n * International normalized ratio (INR) above UNL\n * Fibrinogen outside normal range of 1.6 - 4.2 gram pr. Liter (g/L)\n * C-reactive protein (CRP) above 5 milligram pr. Liter (mg/L) (males) and above 8 mg/L (females)\n4. Use of prescription medicinal products or vaccines within 14 days before dosing and/or non prescription medicinal products within 7 days before dosing.\n\nExceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses."}, 'identificationModule': {'nctId': 'NCT06336005', 'briefTitle': 'A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy People', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A First Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Target Engagement of Single Doses of NNC6022-0001 in Healthy Adults.', 'orgStudyIdInfo': {'id': 'NN6022-7683'}, 'secondaryIdInfos': [{'id': 'U1111-1290-1002', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2023-505026-34', 'type': 'REGISTRY', 'domain': 'European Medical Agency (EMA)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NNC6022-0001', 'description': 'Participants will be randomised to NNC6022-0001.', 'interventionNames': ['Drug: NNC6022-0001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (NNC6022-0001)', 'description': 'Participants will be randomised to placebo.', 'interventionNames': ['Drug: Placebo (NNC6022-0001)']}], 'interventions': [{'name': 'NNC6022-0001', 'type': 'DRUG', 'description': 'Participants will recieve single ascending dose (SAD) of NNC6022-0001. Dose is given in escalating manner for up to seven cohorts.', 'armGroupLabels': ['NNC6022-0001']}, {'name': 'Placebo (NNC6022-0001)', 'type': 'DRUG', 'description': 'Participants will recieve single ascending dose (SAD) of placebo. Placebo is given in escalating manner for up to seven cohorts', 'armGroupLabels': ['Placebo (NNC6022-0001)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9728 NZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'ICON - location Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Clinical Transparency (Dept. 2834).', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'https://www.novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}