[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614981":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":29,"responsibleParty":46,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":11,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":11,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GenSci098","EXPERIMENTAL",null,[13],"Drug: GenSci098",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","* Administration: Only one dose of GenSci098 will be given.\n* Route of Administration: Subcutaneous (injected under the skin).\n* Dose Levels: • Dose 1 • Dose 2• Dose 3• Dose 4",[9],[20],{"name":21,"affiliation":22,"role":23},"Zhongyan Shan, PHD","First Hospital of China Medical University","PRINCIPAL_INVESTIGATOR",[25],{"name":21,"role":26,"phone":27,"phoneExt":11,"email":28},"CONTACT","+86 24 8328 2152","shanzhongyan@hotmail.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"The First Affiliated Hospital of China Medical University","RECRUITING","Shenyang","Liaoning","110801","China","CN",{"type":39,"coordinates":40},"Point",[41,42],123.43278,41.79222,{"lat":42,"lon":41},[45],{"name":21,"role":26,"phone":27,"phoneExt":11,"email":28},{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100614981","phase-1-a-study-of-genssci098-in-subjects-with-graves-disease-100614981",false,"NCT07286656","A Study of GensSci098 in Subjects With Graves' Disease","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Dose of GenSci098 in Patients With Graves' Disease","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Voluntary signed informed consent.\n* Confirmed diagnosis of diffuse toxic goiter (Graves' disease).\n* Abnormal thyroid function tests (e.g., elevated T4, and suppressed TSH).\n* No prior or recent use of antithyroid medications (discontinued for at least 4 weeks).\n* Female participants must be postmenopausal, surgically sterile, or using a highly effective method of contraception.\n* Male participants must agree to practice abstinence, use a highly effective method of contraception， or have undergone vasectomy.\n* Ability to comply with the follow-up schedule and understand and adhere to the study requirements.\n\nExclusion Criteria:\n\n* Non-diffuse toxic goiter-induced hyperthyroidism.\n* Previous radioactive iodine treatment or thyroid surgery.\n* History or risk of thyroid storm.\n* Use of thyroid hormone medications within the past 6 weeks.\n* accompanied by active thyroid eye disease.\n* Thyroid eye disease treated with radiation\u002Fsurgery,or need for urgent surgery surgical or medical intervention.\n* Optic nerve lesions or corneal damage.\n* Use of steroids or immunosuppressants within the past 3 months,or those who have used biologics within 6 months\n* Inability to quit smoking during the study.\n* Allergy to the study drug or monoclonal antibodies.\n* Participation in another clinical trial within the past 3 months.\n* Abnormal electrocardiogram.\n* Significant hepatic or renal dysfunction.\n* Pregnancy,breastfeeding,or positive pregnancy test.\n* Positive for HIV,syphilis,hepatitis B,or hepatitis C.\n* History of drug or substance abuse.\n* Other autoimmune diseases requiring treatment.\n* History of malignant tumors.\n* Splenectomy or major surgery within the past 6 months.\n* Severe cardiovascular,pulmonary,hepatic,renal,neurological,or hematological diseases.\n* Other conditions deemed unsuitable by investigators.","ALL","18 Years",{"count":58,"type":59},24,"ESTIMATED","INTERVENTIONAL",[62],"PHASE1","To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease",[65,66,9,67],"Safety","Tolerability","Graves Disease","2026-02-13",{"date":70,"type":71},"2026-02-17","ACTUAL",{"date":73,"type":71},"2025-11-21",{"date":75,"type":59},"2027-03-18",{"name":5,"class":6},1]