Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-04 @ 7:51 AM
Study NCT ID:
NCT01808469
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2013-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}], 'ancestors': [{'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-23', 'studyFirstSubmitDate': '2013-02-18', 'studyFirstSubmitQcDate': '2013-03-07', 'lastUpdatePostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of NI-0101 in healthy male/female subjects', 'timeFrame': 'Up to 8 weeks', 'description': '* 12 lead ECG\n* Vital signs\n* Physical examination\n* Adverse events\n* Routine laboratory assessments\n\nduring 8 weeks post administration.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameters of NI-0101', 'timeFrame': 'Up to 8 weeks', 'description': 'Blood samples for plasma NI-0101 concentrations.\n\nThe following pharmacokinetic parameters of NI-0101 will be measured:\n\nArea under the curve from the time of dosing extrapolated to infinity (AUCinf); Area under curve from the time of dosing to the last measurable concentration (AUClast); AUCinf - AUClast expressed in % of AUCinf (% AUCextr); Systemic drug clearance (CL); Mean residence time (MRT) extrapolated to infinity (MRTinf); Mean residence time (MRT) at last measurable concentration (MRTlast).'}, {'measure': 'Pharmacodynamic parameters of NI-0101', 'timeFrame': 'Up to 8 weeks', 'description': 'Blood samples for inflammatory markers measured in blood with or without the presence of an exogenous stimulus (lipopolysaccharide).\n\nCytokine levels induced by ex vivo lipopolysaccharide challenge and circulating cytokine levels induced by in vivo lipopolysaccharide challenge will be measured.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety, tolerability and distribution and elimination of a novel therapeutic drug when administered to Healthy Volunteers. In addition its effects on some inflammatory parameters will be measured in presence or absence of lipopolysaccharide stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults between 18 and 40 years old (inclusive) having a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), able to adhere to study protocol requirements and having signed informed consent.\n\nExclusion Criteria:\n\n* Any abnormal past or present clinically relevant medical history or any relevant abnormal laboratory parameters at screening that will prevent to consider the volunteers as healthy for the study.'}, 'identificationModule': {'nctId': 'NCT01808469', 'acronym': 'NI-0101-01', 'briefTitle': 'First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Light Chain Bioscience - Novimmune SA'}, 'officialTitle': 'A Randomized, Double Blind, Placebo-controlled, Pharmacokinetics/Pharmacodynamics-guided, Phase I Study in Healthy Volunteers Given Escalating, Single Intravenous Doses of NI-0101 in the Absence and Then in the Presence of a Systemic Lipopolysaccharide Challenge.', 'orgStudyIdInfo': {'id': 'NI-0101-01_'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NI-0101', 'description': 'NI-0101 is an anti-Toll-like receptor monoclonal antibody.', 'interventionNames': ['Biological: Monoclonal antibody']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo to be used for the proposed clinical trial is a sterile solution for intravenous infusion. The placebo is identical to the NI-0101 drug product but does not include the active substance.', 'interventionNames': ['Biological: Monoclonal antibody']}], 'interventions': [{'name': 'Monoclonal antibody', 'type': 'BIOLOGICAL', 'armGroupLabels': ['NI-0101', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333 CL', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Centre for Human Drug Research', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'J. Koos Prof. Burggraaf, MD, Ph', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Light Chain Bioscience - Novimmune SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}