Actively Recruiting
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
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-02-17
24
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating GenSci098, a drug given as single ascending subcutaneous doses, in adults with Graves' Disease to study its safety and tolerability. This phase 1 clinical trial aims to understand the effects of GenSci098 on patients with confirmed diffuse toxic goiter and abnormal thyroid function. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. and focuses on monitoring adverse events and drug behavior in the body. Participants will receive only one dose of GenSci098 injected under the skin at one of several dose levels. The study includes a follow-up period lasting 141 days, during which safety and tolerability will be assessed. There is no placebo or control group, and the trial is not blinded. The focus is on careful monitoring after the single dose administration. Throughout the study, participants will undergo physical exams, vital sign checks, laboratory tests, and 12-lead electrocardiograms to detect any adverse effects. Researchers will track the incidence and severity of adverse events during the 141-day observation window. Participants must comply with the follow-up schedule and study requirements to ensure accurate safety monitoring and data collection.
CONDITIONS
Brief 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
- Voluntary signed informed consent
- Confirmed diagnosis of diffuse toxic goiter (Graves' disease)
- Abnormal thyroid function tests (elevated T4 and suppressed TSH)
- No use of antithyroid medications for at least 4 weeks prior
- Female participants must be postmenopausal, surgically sterile, or using effective contraception
- Male participants must agree to abstinence, effective contraception, or have had a vasectomy
- Ability to comply with follow-up schedule and study requirements
You will not qualify if you...
- Hyperthyroidism not caused by diffuse toxic goiter
- Previous radioactive iodine treatment or thyroid surgery
- History or risk of thyroid storm
- Use of thyroid hormone medications within past 6 weeks
- Active thyroid eye disease
- Thyroid eye disease treated with radiation/surgery or requiring urgent intervention
- Optic nerve lesions or corneal damage
- Use of steroids, immunosuppressants within past 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 past 3 months
- Abnormal electrocardiogram
- Significant liver or kidney problems
- Pregnancy, breastfeeding, or positive pregnancy test
- Positive for HIV, syphilis, hepatitis B or C
- History of drug or substance abuse
- Other autoimmune diseases needing treatment
- History of malignant tumors
- Splenectomy or major surgery within past 6 months
- Severe cardiovascular, lung, 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 141 days
Participants receive a single subcutaneous dose of GenSci098 at one of four dose levels.
Multiple visits over approximately 141 days for safety and tolerability assessments
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
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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