[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614235":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":44,"centralContacts":48,"locations":57,"responsibleParty":174,"collaborators":40,"id":176,"slug":177,"hasResults":178,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":40,"eligibilityCriteria":182,"healthyVolunteers":183,"sex":184,"minAge":185,"maxAge":186,"enrollmentInfo":187,"targetDuration":40,"studyType":190,"phases":191,"briefSummary":193,"conditions":194,"keywords":40,"overallStatus":60,"whyStopped":40,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},{"fullName":5,"class":6},"Eli Lilly and Company","INDUSTRY",[8,14,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"LY4298445 (Part A1)","EXPERIMENTAL","Single-ascending dose (SAD) of LY4298445 administered subcutaneously (SC) or intravenously (IV) in healthy participants",[13],"Drug: LY4298445",{"label":15,"type":16,"description":17,"interventionNames":18},"LY4298445 Placebo (Part A1)","PLACEBO_COMPARATOR","SAD of LY4298445 administered SC or IV in healthy participants",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"LY4298445 (Part A2)","SAD of LY4298445 administered SC in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA)",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"LY4298445 (Part B)","Multiple-ascending doses (MAD) of LY4298445 administered SC in participants with SLE or RA",[13],{"label":28,"type":10,"description":29,"interventionNames":30},"LY4298445 (Part C)","Single dose of LY4298445 administered SC in healthy Japanese and Chinese participants",[13],{"label":32,"type":16,"description":29,"interventionNames":33},"LY4298445 Placebo (Part C)",[13],[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","LY4298445","Administered SC",[9,20,24,28,15,32],null,{"type":36,"name":37,"description":42,"armGroupLabels":43,"otherNames":40},"Administered IV",[9,15],[45],{"name":46,"affiliation":5,"role":47},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC\u002FGMT - 5 hours, EST)","STUDY_DIRECTOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":40,"email":53},"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)","CONTACT","1-317-615-4559","LillyTrials@Lilly.com",{"name":55,"role":51,"phone":40,"phoneExt":40,"email":56},"Physicians interested in becoming principal investigators please contact","clinical_inquiry_hub@lilly.com",[58,77,90,107,118,132,146,160],{"facility":59,"status":60,"city":61,"state":40,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Nucleus Network","RECRUITING","Brisbane","4006","Australia","AU",{"type":66,"coordinates":67},"Point",[68,69],153.02809,-27.46794,{"lat":69,"lon":68},[72,74],{"name":40,"role":51,"phone":73,"phoneExt":40,"email":40},"+617 3707 2720",{"name":75,"role":76,"phone":40,"phoneExt":40,"email":40},"Gloria Wong","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":60,"city":78,"state":40,"zip":79,"country":63,"countryCode":64,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Melbourne","VIC 3004",{"type":66,"coordinates":81},[82,83],144.96332,-37.814,{"lat":83,"lon":82},[86,88],{"name":40,"role":51,"phone":87,"phoneExt":40,"email":40},"+61 1800 243 733",{"name":89,"role":76,"phone":40,"phoneExt":40,"email":40},"Christina Catherine Chang",{"facility":91,"status":92,"city":93,"state":40,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Peking University First Hospital","NOT_YET_RECRUITING","Beijing","100034","China","CN",{"type":66,"coordinates":98},[99,100],116.39723,39.9075,{"lat":100,"lon":99},[103,105],{"name":40,"role":51,"phone":104,"phoneExt":40,"email":40},"010-83572211",{"name":106,"role":76,"phone":40,"phoneExt":40,"email":40},"Zhuoli Zhang",{"facility":108,"status":92,"city":93,"state":40,"zip":109,"country":95,"countryCode":96,"cosmosGeoPoint":110,"geoPoint":112,"contacts":113},"Peking University Third Hospital","100191",{"type":66,"coordinates":111},[99,100],{"lat":100,"lon":99},[114,116],{"name":40,"role":51,"phone":115,"phoneExt":40,"email":40},"010-82266699",{"name":117,"role":76,"phone":40,"phoneExt":40,"email":40},"Rong MU",{"facility":119,"status":92,"city":120,"state":40,"zip":121,"country":95,"countryCode":96,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Xiangya Hospital of Central South University","Changsha","410008",{"type":66,"coordinates":123},[124,125],112.97087,28.19874,{"lat":125,"lon":124},[128,130],{"name":40,"role":51,"phone":129,"phoneExt":40,"email":40},"0731-89753999",{"name":131,"role":76,"phone":40,"phoneExt":40,"email":40},"Hui LUO",{"facility":133,"status":92,"city":134,"state":40,"zip":135,"country":95,"countryCode":96,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Anhui Provincial Hospital","Hefei","230036",{"type":66,"coordinates":137},[138,139],117.28083,31.86389,{"lat":139,"lon":138},[142,144],{"name":40,"role":51,"phone":143,"phoneExt":40,"email":40},"0551-62284920",{"name":145,"role":76,"phone":40,"phoneExt":40,"email":40},"Zhu CHEN",{"facility":147,"status":92,"city":148,"state":40,"zip":149,"country":95,"countryCode":96,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Renji Hospital, Shanghai Jiaotong University School of Medicine","Shanghai","200127",{"type":66,"coordinates":151},[152,153],121.45806,31.22222,{"lat":153,"lon":152},[156,158],{"name":40,"role":51,"phone":157,"phoneExt":40,"email":40},"021-58752345",{"name":159,"role":76,"phone":40,"phoneExt":40,"email":40},"Shuang YE",{"facility":161,"status":92,"city":162,"state":40,"zip":163,"country":95,"countryCode":96,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Union Hospital Tongji Medical College Huazhong University of Science and Technology","Wuhan","430022",{"type":66,"coordinates":165},[166,167],114.26667,30.58333,{"lat":167,"lon":166},[170,172],{"name":40,"role":51,"phone":171,"phoneExt":40,"email":40},"027-85726114",{"name":173,"role":76,"phone":40,"phoneExt":40,"email":40},"Qiubai LI",{"type":175,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100614235","phase-1-a-study-of-ly4298445-in-healthy-participants-and-participants-with-systemic-lupus-erythematosus-sle-or-rheumatoid-arthritis-ra-100614235",false,"NCT07276958","A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)","A Phase 1, Multicenter, Randomized, Placebo-Controlled, Participant-Blind, Single-Ascending Dose Study of LY4298445 in Healthy Participants and an Open-Label Single-Ascending Dose and Multiple-Ascending Dose Study of LY4298445 in Participants With Systemic Lupus Erythematosus or Rheumatoid Arthritis","Inclusion Criteria: Healthy Participants\n\nHealthy participants between the ages of 18 and 55 years.\n\n* Have body weight of at least 50 kilograms (kg) and body mass index (BMI) between 18 and 32 kilogram per square meter (kg\u002Fm²), inclusive.\n\nParticipants with Systemic Lupus Erythematosus (SLE)\n\n* Are 18 to 75 years of age, inclusive.\n* Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg\u002Fm², inclusive.\n* Have a clinical diagnosis of SLE according to the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria at least 6 months prior to screening.\n\nParticipants with Rheumatoid Arthritis (RA)\n\n* Are 18 to 75 years of age, inclusive.\n* Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg\u002Fm², inclusive.\n* Have a diagnosis of adult-onset RA for at least 6 months prior to screening, as defined by the 2010 ACR\u002FEULAR classification criteria\n* Have Disease Activity Score in 28 joints (DAS28)-high-sensitivity C-reactive protein (hsCRP) greater than or equal to 4.4.\n* Have positive test results for rheumatoid factor or anti-citrullinated peptide antibodies\n* Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 2 advanced therapies (biological disease-modifying antirheumatic drug \\[bDMARD\\] or targeted synthetic DMARD \\[tsDMARD\\]) after failing a conventional synthetic DMARD (csDMARD).\n\nExclusion Criteria:\n\n* Have known allergies to LY4298445, related compounds, or any components of the formulation\n* Are individuals assigned female at birth (AFAB) who are lactating or have a positive pregnancy test at screening or Day -1.\n* Have severe active lupus-associated renal disease (lupus nephritis) defined clinically and\u002For by\n\n  * urine protein\u002Fcreatinine ratio greater than 200 milligrams per millimole (mg\u002Fmmol) (as an estimate of approximate proteinuria greater than 2 reams (g) per day) or\n  * an estimated glomerular filtration rate (eGFR) less than 40 milliliters per minute (mL\u002Fmin)\u002F1.73 m² at screening, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) 2021.\n  * requiring hemodialysis within 6 months prior to screening\n* Have active central nervous system lupus as defined by ACR nomenclature for neuropsychiatric lupus syndromes and as captured by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K); seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, and cerebrovascular accident, within 2 months prior to screening\n* Have a Class 4 RA according to the ACR revised criteria",true,"ALL","18 Years","55 Years",{"count":188,"type":189},63,"ESTIMATED","INTERVENTIONAL",[192],"PHASE1","The purpose of this study is to investigate the safety and tolerability of LY4298445 in healthy participants and in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). Participation in the study will last up to approximately 52 weeks.",[195,196,197],"Healthy","Systemic Lupus Erythematosus","Rheumatoid Arthritis","2026-06-19",{"date":200,"type":201},"2026-06-23","ACTUAL",{"date":203,"type":201},"2026-02-04",{"date":205,"type":189},"2028-03",{"name":5,"class":6},8]