[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620113":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":28,"centralContacts":34,"locations":42,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":27,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":27,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":90,"whyStopped":27,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: ART002g1 Injection - Dose Group 1 ( Single IV Infusion)","EXPERIMENTAL","Participants will receive a single dose of ART002g1.",[13],"Drug: ART002g1 Injection",{"label":15,"type":10,"description":11,"interventionNames":16},"Experimental: ART002g1 Injection - Dose Group 2 (Single IV Infusion)",[13],{"label":18,"type":10,"description":19,"interventionNames":20},"Experimental: ART002g1 Injection - Extended Dose Group ( Single IV Infusion)","Participants will receive a single Optimal Biological Dose (OBD) of ART002g1, which is based on the results of the ascending dose escalation.",[13],[22],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","ART002g1 Injection","Intravenous (IV) infusion",[9,15,18],null,[29,32],{"name":30,"affiliation":5,"role":31},"Xueying Ding, MD","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":5,"role":31},"Rong Jiang, MD",[35,39],{"name":30,"role":36,"phone":37,"phoneExt":27,"email":38},"CONTACT","+86-02136126102","dingxueying@126.com",{"name":33,"role":36,"phone":40,"phoneExt":27,"email":41},"+86 13795493921","listening39@163.com",[43],{"facility":44,"status":27,"city":45,"state":27,"zip":27,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Shanghai General Hospital","Shanghai","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55,57,58,59],{"name":30,"role":36,"phone":56,"phoneExt":27,"email":38},"+86-021-",{"name":33,"role":36,"phone":27,"phoneExt":27,"email":41},{"name":30,"role":31,"phone":27,"phoneExt":27,"email":27},{"name":33,"role":31,"phone":27,"phoneExt":27,"email":27},{"type":31,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Rong Jiang","Associate Chief Physician",[64],{"name":65,"class":66},"Accuredit Therapeutics US Limited","INDUSTRY","100620113","early-phase-1-early-phase-study-of-art002g1-injection-in-hefh-safety-tolerability-and-preliminary-efficacy-100620113",false,"NCT07353398","Early-phase Study of ART002g1 Injection in HeFH: Safety, Tolerability and Preliminary Efficacy","Early-phase Clinical Study on Safety, Tolerability and Preliminary Efficacy of ART002g1 Injection in the Treatment of Heterozygous Familial Hypercholesterolemia","Subjects must meet all the following criteria to be eligible for enrollment:\n\n1. Male or female, aged 18 to 70 years (inclusive) at the time of signing the Informed Consent Form (ICF);\n2. Body weight between 45 and 90 kg (inclusive) at screening;\n3. Definite diagnosis of heterozygous familial hypercholesterolemia (HeFH), meeting either of the following two criteria (1) or (2):\n\n（1) HeFH diagnosed to be caused by mutations in the LDLR, APOB, or PCSK9 gene;\n\n(2) Meeting 2 out of the 3 following criteria for adults per the Dutch Lipid Clinical Network (DLCN) criteria:\n\n1. Serum LDL-C ≥ 4.7 mmol\u002FL without prior lipid-lowering treatment;\n2. Cutaneous or tendinous xanthomas, or arcus cornealis (in subjects \\\u003C 45 years old);\n3. Presence of FH or early-onset atherosclerotic cardiovascular disease (ASCVD) in first-degree relatives.\n\nSubjects must not be enrolled if they meet any one or more of the following exclusion criteria:\n\n1. Diagnosis of compound heterozygous FH, double heterozygous FH, or homozygous FH (HoFH);\n2. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer ≥ 1 × 10² copies\u002FL; positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody;\n3. Any unstable systemic disease, including but not limited to: unstable angina; cerebrovascular accident or transient ischemic attack (within 6 months prior to screening); myocardial infarction (within 6 months prior to screening); history of heart failure (NYHA Class II-IV); severe arrhythmia requiring pharmacotherapy; liver, kidney, or metabolic diseases; or other unstable systemic diseases as determined by the investigator;\n4. History of percutaneous transluminal coronary angioplasty (PTCA), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG) within 6 months prior to the first dose; or documented severe coronary artery stenosis as confirmed by coronary CT or coronary angiography within 90 days prior to randomization.","ALL","18 Years","70 Years",{"count":78,"type":79},24,"ESTIMATED","INTERVENTIONAL",[82],"EARLY_PHASE1","This study is an open-label, single ascending dose (SAD) study designed to evaluate the safety and tolerability of ART002g1 in patients with heterozygous familial hypercholesterolemia (HeFH) who require further reduction in low-density lipoprotein cholesterol (LDL-C). ART002g1 uses base editing technology, which is designed to interfere with the expression of the PCSK9 gene in the liver, thereby reducing the circulating levels of PCSK9 and LDL-C. The primary objectives of this study are to determine the safety and pharmacodynamic (PD) profiles of ART002g1 in this patient population.",[85],"Heterozygous Familial Hypercholesterolemia",[87,88,89],"ART002g1","LNP","HeFH","NOT_YET_RECRUITING","2026-03-15",{"date":93,"type":94},"2026-03-17","ACTUAL",{"date":96,"type":79},"2026-03-11",{"date":98,"type":79},"2027-07",{"name":5,"class":6},1]