[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611013":3},{"organization":4,"armGroups":7,"interventions":78,"overallOfficials":84,"centralContacts":90,"locations":98,"responsibleParty":132,"collaborators":84,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":84,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":84,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":101,"whyStopped":84,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14,18,22,26,30,34,38,42,46,50,54,58,62,66,72,75],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: OJR520 dose A1","EXPERIMENTAL","Participants will receive OJR520 dose level A1.",[13],"Drug: OJR520",{"label":15,"type":10,"description":16,"interventionNames":17},"Part A: OJR520 dose A2","Participants will receive OJR520 dose level A2.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part A: OJR520 dose A3","Participants will receive OJR520 dose level A3.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part A: OJR520 dose A4","Participants will receive OJR520 dose level A4.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Part A: OJR520 dose A5","Participants will receive OJR520 dose level A5.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Part A: OJR520 dose A6","Participants will receive OJR520 dose level A6.",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Part B: OJR520 dose B1","Participants will receive OJR520 dose level B1.",[13],{"label":39,"type":10,"description":40,"interventionNames":41},"Part B: OJR520 dose B2","Participants will receive OJR520 dose level 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matching placebo.",[71],"Other: Placebo",{"label":73,"type":68,"description":69,"interventionNames":74},"Part B: Placebo",[71],{"label":76,"type":68,"description":69,"interventionNames":77},"Part C: Placebo",[71],[79,85],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"DRUG","OJR520","Participants will receive OJR520 in different dose levels.",[9,15,19,23,27,31,35,39,43,47,51,55,59,63],null,{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":84},"OTHER","Placebo","Participants will receive OJR520 matching placebo.",[67,73,76],[91,96],{"name":92,"role":93,"phone":94,"phoneExt":84,"email":95},"Novartis Pharmaceuticals","CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":92,"role":93,"phone":97,"phoneExt":84,"email":84},"+41613241111",[99,121],{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"Quotient Sciences Sea View","RECRUITING","Miami","Florida","33126","United States","US",{"type":108,"coordinates":109},"Point",[110,111],-80.19366,25.77427,{"lat":111,"lon":110},[114,118],{"name":115,"role":93,"phone":116,"phoneExt":84,"email":117},"Daniela Perez","+1 305 644 9903","daniela.perez@quotientsciences.com",{"name":119,"role":120,"phone":84,"phoneExt":84,"email":84},"Juliet Vento","PRINCIPAL_INVESTIGATOR",{"facility":122,"status":101,"city":123,"state":84,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":84},"Novartis Investigative Site","Berlin","10117","Germany","DE",{"type":108,"coordinates":128},[129,130],13.41053,52.52437,{"lat":130,"lon":129},{"type":133,"investigatorFullName":84,"investigatorTitle":84,"investigatorAffiliation":84,"oldNameTitle":84,"oldOrganization":84},"SPONSOR","100611013","phase-1-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ojr520-in-healthy-volunteers-and-participants-with-chronic-kidney-disease-100611013",false,"NCT07235059","Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease","A Participant- and Investigator--Blinded, Placebo- Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease","Inclusion Criteria:\n\nAble to provide written informed consent before any assessment is performed.\n\nPart A (HV):\n\n• Healthy male and female participants in good health as determined by past medical history, physical examination, vital signs, 12-lead ECG, and laboratory tests at screening and baseline within the normal range.\n\nParts B \\& C (CKD)\n\n• Male and female participants 18 to 65 years of age.\n\nExclusion Criteria:\n\n* Women of childbearing potential.\n* Sexually active males unwilling to use contraception.\n\nPart A (HV):\n\n* Clinically significant abnormal blood pressure, defined as SBP \\\u003C90 mmHg or \\>140 mmHg or DBP \\\u003C55 mmHg or \\>95 mmHg.\n* Abnormal resting HR, defined as \\\u003C45 bpm or \\>90 bpm.\n\nPart B \\& C (CKD)\n\n* History of, or currently active, significant illness or medical disorders including, but not limited to, cancer (except for non-melanoma skin cancer), heart failure NYHA III-IV, heart rhythm abnormalities (e.g., atrial fibrillation, sick sinus syndrome, permanent pacemaker), CKD due to autoimmune disease, kidney transplant, dialysis or any other disease the investigator believes may preclude the participant from participating in the this study.\n* Clinically significant aortic stenosis or mitral insufficiency as identified via echocardiography.\n* History of myocardial infarction (MI), stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or transient ischemic attack (TIA).\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.",true,"ALL","18 Years","65 Years",{"count":146,"type":147},112,"ESTIMATED","INTERVENTIONAL",[150],"PHASE1","The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.",[153],"Chronic Kidney Disease",[81,155,156,157,158,159,160],"safety and tolerability","PK","PD","healthy volunteers","first in human","chronic kidney disease","2026-08-18",{"date":163,"type":164},"2026-08-19","ACTUAL",{"date":166,"type":164},"2025-11-20",{"date":168,"type":147},"2028-01-21",{"name":92,"class":6},2]