NCT07286656 A Study of GensSci098 in Subjects With Graves' Disease
| NCT ID | NCT07286656 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Condition | Safety |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-11-21 |
| Primary Completion | 2026-10-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-11-21 with a primary completion date of 2026-10-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease
Eligibility Criteria
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.
Contact & Investigator
Zhongyan Shan, PHD
PRINCIPAL INVESTIGATOR
First Hospital of China Medical University
Frequently Asked Questions
Who can join the NCT07286656 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Safety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07286656 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07286656 currently recruiting?
Yes, NCT07286656 is actively recruiting participants. Contact the research team at shanzhongyan@hotmail.com for enrollment information.
Where is the NCT07286656 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT07286656 clinical trial?
NCT07286656 is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. The principal investigator is Zhongyan Shan, PHD at First Hospital of China Medical University. The trial plans to enroll 24 participants.