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
• 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.