[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100276723":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":27,"locations":32,"responsibleParty":46,"collaborators":27,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":27,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":27,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":27,"overallStatus":68,"whyStopped":27,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Gantenerumab + Placebo","EXPERIMENTAL","Participants will be randomized to receive gantenerumab HCLF and placebo solution via SC injection according to different sequences for the site of administration and different injection speeds.",[13,14],"Drug: Gantenerumab","Drug: Placebo",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Gantenerumab","Gantenerumab as a HCLF will be administered via SC injection according to assigned treatment sequence.",[9],[22],"RO4909832",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Placebo","Gantenerumab Placebo solution will be administered via SC injection according to assigned treatment sequence.",[9],null,[29],{"name":30,"affiliation":5,"role":31},"Clinical Trials","STUDY_DIRECTOR",[33],{"facility":34,"status":27,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":27},"PRA International Clinical Pharmacology Center (EDS US Clinic)","Lenexa","Kansas","66219","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-94.73357,38.95362,{"lat":44,"lon":43},{"type":47,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100276723","phase-1-a-study-to-assess-the-impact-of-speed-and-site-of-subcutaneous-injection-on-pain-tolerability-safety-and-pharmacokinetics-of-gantenerumab-in-healthy-participants-100276723",false,"NCT02882009","A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants","A Single-Center, Randomized, Open-Label, Parallel-Group, Placebo-Controlled, Cross-Over Study To Investigate the Impact of Speed of Injection and Site of Injection on Pain, Tolerability, Safety, and Pharmacokinetics Following Subcutaneous Administration of Gantenerumab in Healthy Volunteers","Inclusion Criteria:\n\n* Healthy male and female participants (healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, coagulation, serology, and urinalysis)\n* Body mass index between 18.0 and 30.0 kilograms per meter squared (kg\u002Fm\\^2), inclusive\n* Female participants of childbearing potential must commit to use two acceptable forms of contraception during the study and until at least 6 months after the follow-up visit\n\nExclusion Criteria:\n\n* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis\n* History or suspicion of drugs of abuse or alcohol addiction\n* Smokers who smoke more than 10 cigarettes per day or equivalent amount of tobacco as determined by history\n* Pregnant or lactating women\n* Positive result on hepatitis B virus (HBV), hepatitis C virus (HCV), or Human immunodeficiency virus (HIV)-1 and -2\n* Any familial history of early onset Alzheimer's disease\n* Prior administration of gantenerumab\n* Participation in an investigational drug medicinal product or medical device study within 90 days before dosing or within seven times the elimination half-life, whichever is longer\n* Any abnormal skin conditions or potentially obscuring tattoos, pigmentation, or lesions in the area intended for SC injection",true,"ALL","40 Years","80 Years",{"count":60,"type":61},48,"ESTIMATED","INTERVENTIONAL",[64],"PHASE1","The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to assess pain following subcutaneous (SC) administration of gantenerumab as a high-concentration liquid formulation (HCLF) at different injection speeds. The total duration of the study for each healthy participant will be up to approximately 21 weeks.",[67],"Healthy Volunteer","COMPLETED","2019-06-07",{"date":71,"type":72},"2019-06-11","ACTUAL",{"date":74,"type":72},"2016-08-31",{"date":76,"type":72},"2017-03-22",{"name":5,"class":6},1]