[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575475":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":72,"collaborators":30,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":30,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":30,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":30,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY",[8,15,18,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","9MW3011 or placebo (Randomized 4:1)",[13,14],"Drug: 9MW3011","Drug: 9MW3011 placebo",{"label":16,"type":10,"description":11,"interventionNames":17},"Cohort 2",[13,14],{"label":19,"type":10,"description":11,"interventionNames":20},"Cohort 3",[13,14],{"label":22,"type":10,"description":11,"interventionNames":23},"Cohort 4",[13,14],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","9MW3011","Ascending IV doses administered per protocol",[9,16,19,22],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"9MW3011 placebo",[9,16,19,22],[35],{"name":36,"role":37,"phone":38,"phoneExt":30,"email":39},"Yongrong Lai","CONTACT","+8607715356304","laiyongrong@hotmail.com",[41,57],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The first Affiliated Hospital of Guangxi Medical University","RECRUITING","Nanning","Guangxi","530021","China","CN",{"type":50,"coordinates":51},"Point",[52,53],108.31667,22.81667,{"lat":53,"lon":52},[56],{"name":36,"role":37,"phone":38,"phoneExt":30,"email":39},{"facility":58,"status":43,"city":59,"state":60,"zip":61,"country":47,"countryCode":48,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Hainan General Hospital","Haikou","Hainan","570311",{"type":50,"coordinates":63},[64,65],110.34651,20.03421,{"lat":65,"lon":64},[68],{"name":69,"role":37,"phone":70,"phoneExt":30,"email":71},"Guyun Wang","+86089868642117","wangguyun@126.com",{"type":73,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100575475","phase-1-a-multiple-ascending-dose-study-of-9mw3011-in-patients-with-non-transfusion-dependent--thalassemia-100575475",false,"NCT06772766","A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia","A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Non-transfusion-dependent β- Thalassemia","Key Inclusion Criteria:\n\n1. Male and female subjects aged 18 to 65 years (inclusive)\n2. Subject must have a documented genetic diagnosis of β-thalassemia or hemoglobin E\u002F β-thalassemia\n3. Subjects must meet the criteria for non-transfusion-dependent thalassemia\n4. Subjects must have a baseline hemoglobin level between 70-100 g\u002FL(inclusive), based on 2 consecutive measurements taken at least 1 week apart within 4 weeks before randomization\n5. Subjects must have evidence of iron overload during screening\n6. Subject must have performance status: Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1\n7. Subjects must fully understand the study procedures and methods, voluntarily participate in the trial, and sign an informed consent form\n\nKey Exclusion Criteria:\n\n1. Subjects diagnosed with alpha-thalassemia\n2. Subjects diagnosed with HbS\u002Fbeta-thalassemia or transfusion-dependent beta-thalassemia\n3. Subjects exhibit severe iron overload at the time of screening\n4. In addition to thalassemia, subjects have any other forms of anemia and hematological disorders that the investigator assesses may compromise safety or influence study outcomes\n5. Combined with any significant systemic diseases or psychiatric disorders\n6. Subjects have New York Heart Association (NYHA) Class III-IV heart failure and other cardiovascular diseases within 6 months prior to screening or currently present\n7. During the screening or baseline period, subjects exhibiting a QTcF interval of ≥450ms for males and ≥470ms for females on a 12-lead electrocardiogram (ECG), or presenting an abnormal 12-lead ECG with clinical significance\n8. Uncontrolled hypertension before screening\n9. A history of malignant neoplasm occurring within the last five years\n10. Severe infection requiring hospitalization or intravenous antimicrobial therapy, or uncontrolled systemic bacterial, fungal, or viral active infection\n11. Subject have received concomitant treatment that was not permitted by the protocol\n12. Subjects whose hematological parameters did not meet the inclusion criteria during screening\n13. Subjects with a history of substance abuse, as well as those who yield positive results on substance abuse screening\n14. Subjects who are unable to undergo MRI scans\n15. Pregnant or lactating women\n16. Subjects presenting any other factors deemed unsuitable for participation assessed by the investigator","ALL","18 Years","65 Years",{"count":85,"type":86},40,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","This is a phase Ib, randomized, double-blind, placebo-controlled, multiple ascending dose study . The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics(PK), pharmacodynamics(PD), and immunogenicity of 9MW3011 in patients with non-transfusion-dependent β- thalassemia .",[92],"Beta-Thalassemia","2025-01-09",{"date":95,"type":96},"2025-01-14","ACTUAL",{"date":98,"type":96},"2024-12-30",{"date":100,"type":86},"2026-10",{"name":5,"class":6},2]