🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07286656
Recruiting Phase 1

A Study of GensSci098 in Subjects With Graves' Disease

NCT07286656 · tracked via the Priya Life Science China tracker
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2025-11-21
Last updated
2026-02-17

Condition(s) studied

SafetyTolerabilityGenSci098Graves Disease

Investigational drug(s) / intervention(s)

GenSci098

GenSci098: * 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

Study summary

To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of China Medical University Shenyang Liaoning Recruiting

More Changchun GeneScience Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07286656 on ClinicalTrials.gov ↗ ← All trials in China