[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100194616":3},{"organization":4,"armGroups":7,"interventions":40,"overallOfficials":52,"centralContacts":46,"locations":56,"responsibleParty":68,"collaborators":46,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":46,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":46,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":95,"whyStopped":46,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8,14,18,22,28,31,34,37],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: JNJ-54452840 20 mg","EXPERIMENTAL","Each participant will receive 20 mg of JNJ-54452840 as a single intravenous dose.",[13],"Drug: JNJ-54452840",{"label":15,"type":10,"description":16,"interventionNames":17},"Group A: JNJ-54452840 80 mg","Each participant will receive 80 mg of JNJ-54452840 as a single intravenous dose.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group A: JNJ-54452840 240 mg","Each participant will receive 240 mg of JNJ-54452840 as a single intravenous dose.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Group A: Placebo","PLACEBO_COMPARATOR","Each participant will receive matching placebo as a single intravenous dose.",[27],"Other: Placebo",{"label":29,"type":10,"description":11,"interventionNames":30},"Group B: JNJ-54452840 20 mg",[13],{"label":32,"type":10,"description":16,"interventionNames":33},"Group B: JNJ-54452840 80 mg",[13],{"label":35,"type":10,"description":20,"interventionNames":36},"Group B: JNJ-54452840 240 mg",[13],{"label":38,"type":24,"description":25,"interventionNames":39},"Group B: Placebo",[27],[41,47],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","JNJ-54452840","Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg",[9,19,15,29,35,32],null,{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":46},"OTHER","Placebo","Single matching intravenous dose",[23,38],[53],{"name":54,"affiliation":5,"role":55},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[57],{"facility":46,"status":46,"city":58,"state":59,"zip":46,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":46},"Cypress","California","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-118.03729,33.81696,{"lat":66,"lon":65},{"type":69,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100194616","phase-1-to-assess-the-pharmacokinetics-and-safety-of-single-doses-of-jnj-54452840-in-healthy-japanese-and-caucasian-participants-100194616",false,"NCT01809353","To Assess the Pharmacokinetics and Safety of Single Doses of JNJ-54452840 in Healthy Japanese and Caucasian Participants","A Phase 1 Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Pharmacokinetics and Safety of JNJ-54452840 Following Single Intravenous Doses to Healthy Japanese and Caucasian Subjects","Inclusion Criteria:\n\n* Must be a healthy male with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments - Must be Japanese or Caucasian\n* Japanese participants must have been born in Japan, have resided outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents\n* Caucasian participants must have Caucasian parents\n\nExclusion Criteria:\n\n* History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results\n* Have a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human peptides or protein\n* Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins",true,"MALE","20 Years","55 Years",{"count":82,"type":83},32,"ACTUAL","INTERVENTIONAL",[86],"PHASE1","The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and safety of JNJ-54452840 in healthy participants.",[89],"Healthy",[89,91,92,93,94,43],"Japanese","Caucasian","Male","Pharmacokinetic","COMPLETED","2015-03-20",{"date":98,"type":99},"2015-03-23","ESTIMATED",{"date":101,"type":46},"2013-07",{"date":103,"type":83},"2014-09",{"name":5,"class":6},1]