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

To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease

Inclusion Criteria:

• Age ≥ 18 years.
• Voluntary signed informed consent.
• Confirmed diagnosis of diffuse toxic goiter (Graves' disease).
• Abnormal thyroid function tests (e.g., elevated T4, and suppressed TSH).
• No prior or recent use of antithyroid medications (discontinued for at least 4 weeks).
• 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:

• Non-diffuse toxic goiter-induced hyperthyroidism.
• Previous radioactive iodine treatment or thyroid surgery.
• History or risk of thyroid storm.
• Use of thyroid hormone medications within the past 6 weeks.
• accompanied by active thyroid eye disease.
• Thyroid eye disease treated with radiation/surgery,or need for urgent surgery surgical or medical intervention.
• Optic nerve lesions or corneal damage.
• Use of steroids or immunosuppressants within the past 3 months,or those who have used biologics within 6 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.