A Study of GensSci098 in Subjects With Graves' Disease

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

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

Study Overview

• Status: Recruiting
• Conditions: Graves Disease; Tolerability; Safety; GenSci098
• Intervention / Treatment: Drug: GenSci098

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhongyan Shan, PHD; Phone Number: +86 24 8328 2152; Email: shanzhongyan@hotmail.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110801
      • Recruiting
      • The First Affiliated Hospital of China Medical University
      • Contact: Zhongyan Shan, PHD; Phone Number: +86 24 8328 2152; Email: shanzhongyan@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GenSci098	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG]).	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.	141 days

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Zhongyan Shan, PHD, First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2025
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): March 18, 2027

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Graves Disease
• Other Study ID Numbers: GenSci098-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No