[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619673":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":76,"collaborators":78,"id":81,"slug":25,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":25,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":25,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Ikaria Bioscience Pty Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RN5681","EXPERIMENTAL","Drug: RN5681 Investigational product subcutaneous injections",[13],"Drug: RN5681",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Drug: Placebo control 0.9% normal saline subcutaneous injection",[19],"Drug: Placebo control",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Investigational Product",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo control","0.9% normal saline SC injection",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Dan Xiang","CONTACT","+86 18516063568","dan.xiang@ronatherapeutics.com",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":38},"Jie Zeng","jie.zeng@ronatherapeutics.com",[40,60],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Q-Pharm Pty Ltd.","RECRUITING","Brisbane","Queensland","4006","Australia",{"type":48,"coordinates":49},"Point",[50,51],153.02809,-27.46794,{"lat":51,"lon":50},[54,58],{"name":55,"role":33,"phone":56,"phoneExt":25,"email":57},"Emma Trowbridge","(07) 3707 2720","e.trowbridge@nucleusnetwork.com.au",{"name":55,"role":59,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":61,"status":42,"city":62,"state":63,"zip":64,"country":46,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Nucleus Network Pty Ltd.","Melbourne","Victoria","3004",{"type":48,"coordinates":66},[67,68],144.96332,-37.814,{"lat":68,"lon":67},[71,75],{"name":72,"role":33,"phone":73,"phoneExt":25,"email":74},"Philip Ryan, MD","(03) 8593 9801","p.ryan@nucleusnetwork.com.au",{"name":72,"role":59,"phone":25,"phoneExt":25,"email":25},{"type":77,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[79],{"name":80,"class":6},"Shanghai Rona Therapeutics Co., Ltd.","100619673",false,"NCT07347678","Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers","A Phase 1a, Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers","Inclusion Criteria:\n\n* Body mass index (BMI) 18 to 35 kg\u002Fm2\n* Fasting LDL-C ≥70 mg\u002FdL (1.81 mmol\u002FL) (all SAD cohorts); fasting LDL-C ≥100 mg\u002FdL (2.59 mmol\u002FL) (POC cohort only)\n* Lp(a) at Screening: SAD cohort: ≥25 nmol\u002FL POC cohort: ≥100 nmol\u002FL\n* Fasting triglycerides \\\u003C400 mg\u002FdL (4.51 mmol\u002FL) at Screening\n* No clinically significant abnormalities of hepatic or renal function\n\nExclusion Criteria:\n\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>1.5× the upper limit of normal at screening\n* Hemoglobin A1c (HbA1c) ≥6.5% at screening\n* Current regular smoker (defined as \\>2 cigarettes\u002Fday or \\>10 cigarettes\u002Fweek) within 3 months prior to screening\n* Use of any siRNA, antisense oligonucleotide (ASO), cell and gene therapy, or clustered regularly interspaced short palindromic repeats (CRISPR) agent in the prior 12 months\n* Received any prescription lipid-lowering medication, including but not limited to statins, ezetimibe, and PCSK9 inhibitors to alter serum lipids within 30 days before screening",true,"ALL","18 Years","65 Years",{"count":92,"type":93},60,"ESTIMATED","INTERVENTIONAL",[96],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN5681 in Adult healthy subjects",[99],"High Cholesterol","2026-03-30",{"date":102,"type":103},"2026-04-03","ACTUAL",{"date":105,"type":103},"2026-03-12",{"date":107,"type":93},"2027-07",{"name":5,"class":6},2]