GenSci098, Graves Disease, Safety, Tolerability
Conditions
Brief summary
To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease
Interventions
DRUGGenSci098
* Administration: Only one dose of GenSci098 will be given. * Route of Administration: Subcutaneous (injected under the skin). * Dose Levels: • Dose 1 • Dose 2• Dose 3• Dose 4
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG]). | 141 days | This outcome measure assesses the incidence and severity of adverse events (AEs) experienced by participants during the study. AEs will be monitored through physical examinations, vital signs, laboratory tests, and 12-lead electrocardiograms (ECGs). The assessment period spans from the first dose of the study intervention to 141 days post-dosing. |
Countries
China
Contacts
CONTACTZhongyan Shan, PHD
PRINCIPAL_INVESTIGATORZhongyan Shan, PHD
First Hospital of China Medical University
Outcome results
None listed