Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT07286656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of GensSci098 in Subjects With Graves' Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006111', 'term': 'Graves Disease'}], 'ancestors': [{'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-02-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-12-03', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG]).', 'timeFrame': '141 days', 'description': 'This outcome measure assesses the incidence and severity of adverse events (AEs) experienced by participants during the study. AEs will be monitored through physical examinations, vital signs, laboratory tests, and 12-lead electrocardiograms (ECGs). The assessment period spans from the first dose of the study intervention to 141 days post-dosing.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety', 'Tolerability', 'GenSci098', 'Graves Disease']}, 'descriptionModule': {'briefSummary': "To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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 T3, T4, and suppressed TSH).\n* No prior or recent use of antithyroid medications (discontinued for at least 4 weeks).\n* No thyroid eye disease or only mild thyroid eye disease.\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* Thyroid eye disease treated with radiation/surgery,or need for urgent surgery.\n* Optic nerve lesions or corneal damage.\n* Use of steroids or immunosuppressants within the past 3 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."}, 'identificationModule': {'nctId': 'NCT07286656', 'briefTitle': "A Study of GensSci098 in Subjects With Graves' Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'GenSci098-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GenSci098', 'interventionNames': ['Drug: GenSci098']}], 'interventions': [{'name': 'GenSci098', 'type': 'DRUG', 'description': '* 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', 'armGroupLabels': ['GenSci098']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110801', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'contacts': [{'name': 'Zhongyan Shan, PHD', 'role': 'CONTACT', 'email': 'shanzhongyan@hotmail.com', 'phone': '+86 24 8328 2152'}], 'facility': 'The First Affiliated Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Zhongyan Shan, PHD', 'role': 'CONTACT', 'email': 'shanzhongyan@hotmail.com', 'phone': '+86 24 8328 2152'}], 'overallOfficials': [{'name': 'Zhongyan Shan, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Hospital of China Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}