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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Page 1 of 1 (1 locations)

1

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China, 110801

A Study of GensSci098 in Subjects With Graves' Disease | DecenTrialz