Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2025-12-09
2027-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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GenSci098
GenSci098
* Administration: Only one dose of GenSci098 will be given.
* Route of Administration: Subcutaneous (injected under the skin).
* Dose Levels: • Dose 1 • Dose 2• Dose 3• Dose 4
Interventions
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GenSci098
* Administration: Only one dose of GenSci098 will be given.
* Route of Administration: Subcutaneous (injected under the skin).
* Dose Levels: • Dose 1 • Dose 2• Dose 3• Dose 4
Eligibility Criteria
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Inclusion Criteria
* Voluntary signed informed consent.
* Confirmed diagnosis of diffuse toxic goiter (Graves' disease).
* Abnormal thyroid function tests (e.g., elevated T3, T4, and suppressed TSH).
* No prior or recent use of antithyroid medications (discontinued for at least 4 weeks).
* No thyroid eye disease or only mild thyroid eye disease.
* Female participants must be postmenopausal, surgically sterile, or using a highly effective method of contraception.
* Male participants must agree to practice abstinence, use a highly effective method of contraception， or have undergone vasectomy.
* Ability to comply with the follow-up schedule and understand and adhere to the study requirements.
Exclusion Criteria
* Previous radioactive iodine treatment or thyroid surgery.
* History or risk of thyroid storm.
* Use of thyroid hormone medications within the past 6 weeks.
* Thyroid eye disease treated with radiation/surgery,or need for urgent surgery.
* Optic nerve lesions or corneal damage.
* Use of steroids or immunosuppressants within the past 3 months.
* Inability to quit smoking during the study.
* Allergy to the study drug or monoclonal antibodies.
* Participation in another clinical trial within the past 3 months.
* Abnormal electrocardiogram.
* Significant hepatic or renal dysfunction.
* Pregnancy,breastfeeding,or positive pregnancy test.
* Positive for HIV,syphilis,hepatitis B,or hepatitis C.
* History of drug or substance abuse.
* Other autoimmune diseases requiring treatment.
* History of malignant tumors.
* Splenectomy or major surgery within the past 6 months.
* Severe cardiovascular,pulmonary,hepatic,renal,neurological,or hematological diseases.
* Other conditions deemed unsuitable by investigators.
18 Years
ALL
No
Sponsors
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Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Zhongyan Shan, PHD
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
Locations
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The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GenSci098-102
Identifier Type: -
Identifier Source: org_study_id