Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT01228669
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2010-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D002836', 'term': 'Hemophilia B'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2012-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2010-10-25', 'studyFirstSubmitQcDate': '2010-10-25', 'lastUpdatePostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse Events (AEs), including Serious Adverse Events (SAEs)', 'timeFrame': 'from trial product administration until 43 days after trial product administration'}], 'secondaryOutcomes': [{'measure': 'Area under the concentration-time curve', 'timeFrame': 'from 43 days after trial product administration until 53 days after trial product administration'}, {'measure': 'Adverse Events (AEs), including Serious Adverse Events (SAEs)', 'timeFrame': 'from 43 days after trial product administration until 53 days after trial product administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Bleeding Disorder', 'Haemophilia A', 'Haemophilia B', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '25641556', 'type': 'RESULT', 'citation': 'Chowdary P, Lethagen S, Friedrich U, Brand B, Hay C, Abdul Karim F, Klamroth R, Knoebl P, Laffan M, Mahlangu J, Miesbach W, Dalsgaard Nielsen J, Martin-Salces M, Angchaisuksiri P. Safety and pharmacokinetics of anti-TFPI antibody (concizumab) in healthy volunteers and patients with hemophilia: a randomized first human dose trial. J Thromb Haemost. 2015 May;13(5):743-54. doi: 10.1111/jth.12864. Epub 2015 Apr 6.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight between 50 and 100 kg, both inclusive\n* Body mass index (BMI) between 18.0 kg/m2 and 25.0 kg/m2, both inclusive\n* For haemophilia subjects only: Diagnosed with severe haemophilia A or B\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to trial product(s) or related products\n* Surgery planned to occur during the trial\n* Any major and/or orthopaedic surgery within 30 days prior to trial product administration'}, 'identificationModule': {'nctId': 'NCT01228669', 'acronym': 'Explorer 1', 'briefTitle': 'Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multi-centre, Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-0000-2021 Administered Intravenously and Subcutaneously to Healthy Male Subjects and Haemophilia Subjects', 'orgStudyIdInfo': {'id': 'NN7415-3813'}, 'secondaryIdInfos': [{'id': '2010-020465-24', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1116-2356', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: NNC 0172-0000-2021']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: NNC 0172-0000-2021']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'NNC 0172-0000-2021', 'type': 'DRUG', 'description': 'Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose', 'armGroupLabels': ['A']}, {'name': 'NNC 0172-0000-2021', 'type': 'DRUG', 'description': 'Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.', 'armGroupLabels': ['B']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '10249', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '60590', 'city': 'Frankfurt/M.', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '20124', 'city': 'Milan', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '50400', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '0699', 'city': 'Polokwane', 'state': 'Limpopo', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -23.90449, 'lon': 29.46885}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': 'HA1 3UJ', 'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0NN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}