Actively Recruiting
A Study of GensSci098 in Subjects With Graves' Disease
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-02-17
24
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease
CONDITIONS
Official Title
A Study of GensSci098 in Subjects With Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Signed informed consent voluntarily
- Confirmed diagnosis of diffuse toxic goiter (Graves' disease)
- Abnormal thyroid function tests, such as elevated T4 and suppressed TSH
- No antithyroid medications used for at least 4 weeks prior
- Female participants must be postmenopausal, surgically sterile, or using highly effective contraception
- Male participants must abstain, use highly effective contraception, or have had a vasectomy
- Ability to comply with follow-up and study requirements
You will not qualify if you...
- Hyperthyroidism caused by non-diffuse toxic goiter
- Prior radioactive iodine treatment or thyroid surgery
- History or risk of thyroid storm
- Use of thyroid hormone medications within the past 6 weeks
- Active thyroid eye disease or history of treatment with radiation or surgery
- Optic nerve lesions or corneal damage
- Use of steroids, immunosuppressants within 3 months, or biologics within 6 months
- Inability to quit smoking during the study
- Allergy to study drug or monoclonal antibodies
- Participation in another clinical trial within 3 months
- Abnormal electrocardiogram
- Significant liver or kidney dysfunction
- Pregnancy, breastfeeding, or positive pregnancy test
- Positive for HIV, syphilis, hepatitis B or C
- History of drug or substance abuse
- Other autoimmune diseases requiring treatment
- History of malignant tumors
- Splenectomy or major surgery in the past 6 months
- Severe cardiovascular, pulmonary, liver, kidney, neurological, or blood diseases
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110801
Actively Recruiting
Research Team
Z
Zhongyan Shan, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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