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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of China Medical University
RECRUITING
Shenyang
Contact Information
Primary
Zhongyan Shan, PHD
shanzhongyan@hotmail.com
+86 24 8328 2152
Time Frame
Start Date: 2025-11-21
Estimated Completion Date: 2027-03-18
Participants
Target number of participants: 24
Treatments
Experimental: GenSci098
Related Therapeutic Areas
Sponsors
Leads: Changchun GeneScience Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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