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Official title A Study of GensSci098 in Subjects With Graves' Disease
ClinicalTrials.gov ID: NCT07286656
What this study is testing
What is GenSci098?
GenSci098 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for safety.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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).
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.