[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100368572":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":53,"centralContacts":11,"locations":57,"responsibleParty":64,"collaborators":11,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":11,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":11,"overallStatus":85,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Ono Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"ONO-4685 (PartA, D)","EXPERIMENTAL",null,[13],"Biological: ONO-4685",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo (PartA, D)","PLACEBO_COMPARATOR",[18],"Biological: Placebo",{"label":20,"type":10,"description":11,"interventionNames":21},"KLH+placebo (Part B)",[22],"Biological: KLH",{"label":24,"type":10,"description":11,"interventionNames":25},"KLH+ONO-4685 (PartC)",[26],"Biological: KLH, ONO-4685",{"label":28,"type":10,"description":11,"interventionNames":29},"KLH+placebo (PartC)",[30],"Biological: KLH, placebo",[32,37,41,45,49],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"BIOLOGICAL","ONO-4685","Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed.",[9],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"Placebo","Placebo will be administered by intravenous continuous infusion at the designated speed.",[15],{"type":33,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"KLH","KLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration.",[20],{"type":33,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"KLH, ONO-4685","Part C will be conducted in a study design that ONO-4685 will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose regimens selected according to the investigation result in Part B.",[24],{"type":33,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"KLH, placebo","Part C will be conducted in a study design that placebo will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose resimens selected according to the investigation result in Part B.",[28],[54],{"name":55,"affiliation":5,"role":56},"Junichiro Manako","STUDY_DIRECTOR",[58],{"facility":59,"status":11,"city":60,"state":61,"zip":11,"country":62,"countryCode":63,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Fukuoka Clinical Site","Hakata","Fukuoka","Japan","JP",{"type":65,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100368572","phase-1-single-ascending-dose-study-to-assess-the-safety-tolerability-pk-and-pd-of-ono-4685-in-japanese-and-caucasian-healthy-adult-male-subjects-100368572",false,"NCT04079062","Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects","Inclusion Criteria:\n\n* Japanese healthy adult male subjects (PartA, B, and C)\n* Caucasian healthy adult male subjects (Part D)\n* Age (at the time of informed consent): ≥20 yeas, ≤ 45 yeas\n* Body weight (at the time of screening test): ≥50 kg\n\nExclusion Criteria:\n\n* Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and\u002For other disease.\n* Subjects with current or with a history of severe allergy to drugs or foods\n* Subjects with current or with a history of drug or alcohol abuse",true,"MALE","20 Years","45 Years",{"count":77,"type":78},78,"ACTUAL","INTERVENTIONAL",[81],"PHASE1","To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a single-dose by intravenous infusion.",[84],"Healthy Volunteers","COMPLETED","2024-05-02",{"date":88,"type":78},"2024-05-03",{"date":90,"type":78},"2019-09-12",{"date":92,"type":78},"2021-05-25",{"name":5,"class":6},1]