Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-28 @ 12:30 PM
Study NCT ID:
NCT02016066
Status:
WITHDRAWN
Last Update Posted:
2017-02-06
First Post:
2013-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Pharmacokinetics and Immunogenicity of CR6261 in Japanese Healthy Participants
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study terminated due to business decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2013-12-14', 'studyFirstSubmitQcDate': '2013-12-14', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'Up to 76 days'}], 'secondaryOutcomes': [{'measure': 'Maximum observed serum CR6261 concentration', 'timeFrame': 'Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 76 or early withdrawal day'}, {'measure': 'Time to reach the maximum observed serum CR6261 concentration', 'timeFrame': 'Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 76 or early withdrawal day'}, {'measure': 'Area under the serum CR6261 concentration-time curve', 'timeFrame': 'Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 76 or early withdrawal day'}, {'measure': 'Level of antibodies to CR6261 in serum samples', 'timeFrame': 'Day 1 (predose), Day 29, Day 57, Day 76 or early withdrawal day', 'description': 'Level of antibodies to CR6261 in serum samples will evaluate immunogenecity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy', 'CR6261', 'Japanese', 'Safety', 'Pharmacokinetics', 'Immunogenicity'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the drug) and immunogenicity (ability of a particular substance to provoke an immune response in the human body) of CR6261 in Japanese healthy participants', 'detailedDescription': 'This study is a randomized (study medication is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (placebo comparator is compared with the study medication to evaluate safety profile of the study medication in clinical study), single-dose study in Japanese healthy adult male participants. The study will include screening phase (28 to 2 days prior to the study medication administration), treatment phase (Study medication will be administered on Day 1), and follow-up phase (up to 76 days). Twelve participants will be randomly assigned to CR6261 50 mg/kg or placebo groups in a 2:1 ratio and receive an assigned treatment on Day 1. Safety will be assessed by evaluating adverse events, clinical laboratory tests, 12-lead Electrocardiogram, vital signs, and physical examination. Total maximum duration of participation of an individual participant will be 104 days.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have signed an informed consent document\n* Body mass index between 18 and 30 kg/m2, with body weight greater than or equal to 50 kg at screening\n* Must agree to use an adequate contraception method (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm from the study drug administration until Day 76\n* Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at screening\n* Non-smoker or participant who smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before the study drug administration\n\nExclusion Criteria:\n\n* History of or current clinically significant medical illness determined by the investigators including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, and coagulation disorders\n* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis\n* Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram\n* A diagnosis of influenza infection or any constellation of clinical symptoms consistent with influenza infection within 14 days before the study drug administration is scheduled\n* Participants with a fever of over 37.5°C on Day -1 or at predose'}, 'identificationModule': {'nctId': 'NCT02016066', 'briefTitle': 'A Study to Assess the Safety, Pharmacokinetics and Immunogenicity of CR6261 in Japanese Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Pharmaceutical K.K.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Japanese Subjects to Assess the Safety, Pharmacokinetics and Immunogenicity of CR6261 Following Single Intravenous Administration', 'orgStudyIdInfo': {'id': 'CR102897'}, 'secondaryIdInfos': [{'id': 'CR6261FLZ1003', 'type': 'OTHER', 'domain': 'Janssen Pharmaceutical K.K., Japan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CR6261', 'interventionNames': ['Drug: CR6261']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CR6261', 'type': 'DRUG', 'description': 'CR6261 50 mg/kg solution will be administered as a single 2-hour intravenous infusion', 'armGroupLabels': ['CR6261']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered as a single 2-hour intravenous infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Janssen Pharmaceutical K.K., Japan Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Pharmaceutical K.K.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Pharmaceutical K.K.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}