Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT07286656
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years.
* 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:
* 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.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07286656
Study Brief:
Protocol Section:
NCT07286656