Actively Recruiting
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Subcutaneous Doses of GenSci098 in TED Patients
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-02-11
76
Participants Needed
1
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of single and multiple increasing doses of GenSci098 given under the skin in patients with active thyroid eye disease (TED) related to Graves' disease. This Phase 1 clinical trial aims to understand how the body processes this drug and to monitor for any side effects. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. Participants will receive subcutaneous injections of GenSci098 at one of five dose levels (15mg, 45mg, 90mg, 180mg, or 270mg) or a matching placebo. The study includes two parts: a single ascending dose (SAD) phase where participants receive one dose, and a multiple ascending dose (MAD) phase where participants receive repeated doses. The study uses a randomized and quadruple-blind design to compare GenSci098 and placebo. During the study, participants will be monitored for adverse events through physical exams, vital signs, laboratory tests, and ECGs over periods of up to 169 days in the SAD part and 281 days in the MAD part. Researchers will also measure how GenSci098 moves through and acts in the body, including antibody responses. Participants will be asked to comply with study treatments and assessments until the study ends.
CONDITIONS
Brief Title
A Study of GenSci098 in Subjects With Active Thyroid Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years at the time of informed consent
- Diagnosed with active thyroid eye disease (TED) related to Graves' disease with a clinical activity score (CAS) of 3 or higher in the most affected eye
- Symptom onset of active TED within 12 months before screening
- Positive for thyroid stimulating hormone receptor antibodies (TRAb) at screening
- Moderate to severe TED impacting quality of life, with at least two specific manifestations such as eyelid retraction or proptosis
- Euthyroid or mild thyroid dysfunction as specified for study parts
- Stable or no prior antithyroid or thyroid hormone therapy
- No immediate or planned eye surgery or orbital irradiation during the study
- Female participants must be infertile or agree to use effective contraception from screening until 300 days after last dose
- Male participants must agree to use contraception or abstinence from screening until 24 weeks after last dose
- Able and willing to understand and comply with study procedures until study end
You will not qualify if you...
- Significant vision loss due to optic neuropathy within the past 6 months
- Corneal injury not responding to medical treatment
- Recent significant improvement in TED activity or proptosis before screening
- Prior orbital irradiation or surgery for TED
- Recent use of high-dose steroids or steroids for non-TED conditions
- Recent treatment with biologics or peptides such as teprotumumab
- Recent use of non-steroidal immunosuppressive agents
- Other eye or autoimmune diseases that may affect study participation
- History of non-Graves' hyperthyroidism or thyroid storm (Part 2 only)
- Recent radioiodine treatment or thyroidectomy (Part 2 only)
- Inability to abstain from smoking during the study
- Known allergies to study drug components or prior monoclonal antibody reactions
- History of cancer
- Recent acute or chronic infection
- Participation in another clinical trial recently or concurrently
- Abnormal ECG or significant heart conduction issues
- Liver or kidney function test abnormalities above specified limits
- Positive pregnancy test or lactating women at screening
- Positive tests for hepatitis C, HIV, syphilis, or hepatitis B
- History or current substance abuse or positive drug screen
- Any other medical or laboratory conditions deemed unsafe by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 281 days depending on study part
Participants receive single and multiple ascending subcutaneous doses of GenSci098 or placebo to evaluate safety and tolerability.
Multiple visits during dosing and assessments over treatment period
Duration - Up to 169 days post-treatment
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and immune response after treatment ends.
Multiple follow-up visits for assessments
Trial Site Locations
Total: 1 location
1
Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medication
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
J
Jun Yan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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