[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100166392":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":11,"locations":29,"responsibleParty":43,"collaborators":11,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":11,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":11,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Bristol-Myers Squibb","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Abatacept (BMS-188667) manufactured at Lonza, NH facility","ACTIVE_COMPARATOR",null,[13],"Biological: Abatacept (BMS-188667)",{"label":15,"type":16,"description":11,"interventionNames":17},"Abatacept (BMS-188667) manufactured at Devens, MA facility","EXPERIMENTAL",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","Abatacept (BMS-188667)","Solution for injection, Intravenous, 750 mg, Single dose, 1 day,",[15,9],[25],"BMS-188667",[27],{"name":5,"affiliation":5,"role":28},"STUDY_DIRECTOR",[30],{"facility":31,"status":11,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":11},"Icon Clinical Pharmacology Unit, Llc","Omaha","Nebraska","68154","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-95.94043,41.25626,{"lat":41,"lon":40},{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100166392","phase-1-pharmacokinetic-study-to-compare-the-blood-levels-of-abatacept-manufactured-at-lonza-biologics-to-the-blood-levels-of-abatacept-manufactured-at-the-devens-massachusetts-ma-facility-of-bristol-myers-squibb-100166392",true,"NCT01439204","Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb","A Randomized, Open-label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of Abatacept (BMS-188667) Drug Products Using Active Pharmaceutical Ingredient Manufactured at Devens, MA Site Relative to Active Pharmaceutical Ingredient Manufactured at Lonza, New Hampshire (NH) in Healthy Subjects","Inclusion Criteria:\n\n* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations\n* Body weight will be between 60 and 100 kg, inclusive\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness\n* Any major surgery within 4 weeks of study drug administration\n* Smoking more than 10 cigarettes per day\n* Recent (within 6 months of study drug administration) drug or alcohol abuse.\n* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus-1, Human Immunodeficiency Virus-2 antibody\n* History of any significant drug allergy or asthma\n* Women who are pregnant or breastfeeding and\u002For unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period","ALL","18 Years","55 Years",{"count":56,"type":57},223,"ACTUAL","INTERVENTIONAL",[60],"PHASE1","The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are comparable in healthy subjects",[63],"Rheumatoid Arthritis","COMPLETED","2014-02-21",{"date":67,"type":68},"2014-03-19","ESTIMATED",{"date":70,"type":11},"2011-10",{"date":72,"type":57},"2012-02",{"name":5,"class":6},1]