NCT07286656招募中1 期
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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG]).
研究概览
简要总结
To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
GenSci098
Experimental
干预措施: GenSci098 (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG]).
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (1)
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