Status:
RECRUITING
A Study of GensSci098 in Subjects With Graves' Disease
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions:
Safety
Tolerability
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease
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 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.
Key Trial Info
Start Date :
November 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 18 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07286656
Start Date
November 21 2025
End Date
March 18 2027
Last Update
February 17 2026
Active Locations (1)
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1
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110801