A Study of GensSci098 in Subjects With Graves' Disease

GeneScience Pharmaceuticals (GenSci)

Status and phase

Not yet enrolling

Phase 1

Conditions

Graves Disease

Tolerability

GenSci098

Safety

Treatments

Drug: GenSci098

Study type

Interventional

Funder types

Industry

Identifiers

GenSci098-102

Details and patient eligibility

About

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

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years.
Voluntary signed informed consent.
Confirmed diagnosis of diffuse toxic goiter (Graves' disease).
Abnormal thyroid function tests (e.g., elevated T3, T4, and suppressed TSH).
No prior or recent use of antithyroid medications (discontinued for at least 4 weeks).
No thyroid eye disease or only mild thyroid eye disease.
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.
Thyroid eye disease treated with radiation/surgery,or need for urgent surgery.
Optic nerve lesions or corneal damage.
Use of steroids or immunosuppressants within the past 3 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.