[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100135764":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":42,"centralContacts":47,"locations":48,"responsibleParty":59,"collaborators":47,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":47,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":47,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":47,"overallStatus":81,"whyStopped":47,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Hanmi Pharmaceutical Company Limited","INDUSTRY",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","1.1 mcg\u002Fkg of HM10460A, placebo, or Neulasta",[13],"Drug: HM10460A or placebo or Neulasta",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","3.3 mcg\u002Fkg HM10460A, placebo or Neulasta",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","10 mcg\u002Fkg of HM10460A, placebo, or Neulasta",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 4","30 mcg\u002Fkg of HM10460A, placebo, or Neulasta",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Cohort 5","90 mcg\u002Fkg or HM10460A, placebo, or Neulasta",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Cohort 6","270 mcg\u002Fkg of HM10460A, placebo, or Neulasta",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","HM10460A or placebo or Neulasta","Single SC injection of the appropriate dose of drug ranging from 1.1 mcg\u002Fkg to 270 mcg\u002Fkg.",[9,15,19,23,27,31],[41],"LAPS-G-CSF",[43],{"name":44,"affiliation":45,"role":46},"Hanmi Clinical","California","PRINCIPAL_INVESTIGATOR",null,[49],{"facility":47,"status":47,"city":50,"state":45,"zip":47,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":47},"California City","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-117.9859,35.1258,{"lat":57,"lon":56},{"type":60,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100135764","phase-1-safety-and-pk-of-hm10460a-hnk460-in-healthy-adult-japanese-and-caucasian-subjects-100135764",false,"NCT01037543","Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects","A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and PK of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Japanese and Caucasian Subjects.","Inclusion Criteria:\n\n* BMI of 18 - 29.9 kg\u002Fm2\n* have not used tobacco or nicotine containing products for at least 3 months prior to dosing\n* be able to remain abstinent throughout the study.\n\nExclusion Criteria:\n\n* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.\n* positive urine drug\u002Falcohol testing\n* Positive for HIV, HBsAg, HCV ab\n* History of anaphylactic reaction to medicine or environmental exposure",true,"ALL","20 Years","45 Years",{"count":73,"type":74},84,"ACTUAL","INTERVENTIONAL",[77],"PHASE1","Study Design\n\n* Randomized, double-blind, placebo-controlled, escalating single-dose design.\n* Six ascending dose cohorts\n* In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control), or Neulasta® (positive control).\n* Primary Objective\n* to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Japanese and Caucasian subjects.",[80],"Healthy","COMPLETED","2014-02-05",{"date":84,"type":85},"2014-02-07","ESTIMATED",{"date":87,"type":47},"2009-11",{"date":89,"type":74},"2011-04",{"name":5,"class":6},1]