GenSci098 for adults with Graves' disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, single-ascending-dose study enrolling adults with confirmed diffuse toxic goiter (Graves' disease) to receive subcutaneous GenSci098. Participants will be screened for abnormal thyroid function and must have discontinued recent antithyroid or thyroid hormone treatments per protocol. Small cohorts will receive escalating single doses with close safety monitoring, laboratory testing, and follow-up visits to evaluate tolerability and adverse events. Key exclusions include prior radioactive iodine or thyroid surgery and active thyroid eye disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of China Medical University
  Shenyang, Liaoning, China Recruiting

Study contacts

• Principal investigator: Zhongyan Shan, PHD — First Hospital of China Medical University
• Study coordinator: Zhongyan Shan, PHD
• Email: shanzhongyan@hotmail.com
• Phone: +86 24 8328 2152

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Efgartigimod for Graves' Disease in adults

  We are testing if efgartigimod given under the skin can help adults with Graves' disease by improving thyroid function and whether it is safe and tolerable.

  Recruiting at 35 sites Phase 3 argenx · Carlsbad, California and 34 other locations · NCT07570316

• Evaluating GenSci098 for treating active thyroid eye disease

  This study is testing a new treatment called GenSci098 to see if it is safe and helpful for people with active thyroid eye disease linked to Graves' disease.

  Recruiting Phase 1 Changchun GeneScience Pharmaceutical Co., Ltd. · Shanghai, Shanghai Municipality · NCT06569758

• ETHY-001 safety and activity in Thyroid Eye Disease (TED)

  This study tests ETHY-001 versus placebo to see if it is safe, tolerable, and shows activity in people with thyroid eye disease.

  Recruiting at 2 sites Phase 1 Ethyreal Bio, Inc. · Orland Park, Illinois and 2 other locations · NCT07885605

• Early risk stratification of thyroid eye disease in newly diagnosed Graves' disease

  This study tests whether early eye-related signs, blood and tear biomarkers, or eye surface features can predict who with Graves’ disease will develop thyroid eye disease within a year.

  Recruiting University of Copenhagen · Herlev · NCT07812194

• Felzartamab for Graves’ Disease: See if it helps control thyroids and reduce need for ATDs

  This study tests felzartamab vs placebo in adults with Graves’ disease to see if it can normalize thyroid hormones and let people stop anti-thyroid drugs.

  Recruiting at 14 sites Phase 2 Biogen · Glendale, Arizona and 13 other locations · NCT07722546

• AI-based MRI and ultrasound for thyroid-related eye disease

  This study tests an AI model using orbital MRI and eye ultrasound to help diagnose activity and severity of thyroid-associated ophthalmopathy and predict its course in adults.

  Recruiting Shanghai Changzheng Hospital · Shanghai, Huangpu District · NCT07716397

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.