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Taking peoplePhase 1

A Study of GensSci098 in Subjects With Graves' Disease

Key facts

Phase
Phase 1

This trial has no sites in United States.

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Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Changchun GeneScience Pharmaceutical Co., Ltd.
Trial code
NCT07286656
Record updated
17 February 2026
Original description
To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' DiseaseRead full original descriptionShow less

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Dose of GenSci098 in Patients With Graves' Disease

To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease

Inclusion: 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: Previous radioactive iodine treatment or thyroid surgery; Use of thyroid hormone medications within the past 6 weeks; Thyroid eye disease treated with radiation/surgery,or need for urgent surgery surgical or medical intervention; Use of steroids or immunosuppressants within the past 3 months,or those who have used biologics within 6 months; Splenectomy or major surgery within the past 6 months; accompanied by active thyroid eye disease; Allergy to the study drug or monoclonal antibodies; Positive for HIV,syphilis,hepatitis B,or hepatitis C; History of drug or substance abuse; Other autoimmune diseases requiring treatment; History of malignant tumors; Severe cardiovascular,pulmonary,hepatic,renal,neurological,or hematological diseases; Other conditions deemed unsuitable by investigators; Non-diffuse toxic goiter-induced hyperthyroidism; History or risk of thyroid storm; Optic nerve lesions or corneal damage; Inability to quit smoking during the study; Participation in another clinical trial within the past 3 months; Abnormal electrocardiogram; Significant hepatic or renal dysfunction; Pregnancy,breastfeeding,or positive pregnancy test.

ClinicalTrials.gov NCT07286656