A Study of GensSci098 in Subjects With Graves' Disease

NCT07286656 | Recruiting Phase 1

• 1 other identifier: GenSci098-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety; Tolerability; GenSci098; Graves Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

GenSci098

EXPERIMENTAL

Drug: GenSci098

Interventions

GenSci098 DRUG

* 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

GenSci098

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110801, China

RECRUITING

MeSH Terms

Conditions

Graves Disease

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zhongyan Shan, PHD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongyan Shan, PHD

CONTACT

+86 24 8328 2152; shanzhongyan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): March 18, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)