What is IBI3031 studying for Thyroid Eye Disease?

IBI3031 is being studied to evaluate its safety, tolerability, and how it works in the body for people with Thyroid Eye Disease. This trial looks at single and multiple doses to understand the drug's effects and immune response. The study is sponsored by Innovent Biologics (Suzhou) Co. Ltd.

Who may be eligible for this Thyroid Eye Disease clinical trial?

Adults aged 18 to 75 years with moderate-to-severe active Thyroid Eye Disease may be eligible. Participants should weigh between 45 and 100 kg and have specific thyroid function statuses. Both males and females can join if they meet these and other health criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this Thyroid Eye Disease clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years - 75Years

All Genders

ID07622368

Phase I Study to Assess Safety and Dosage of IBI3031 in Adults with Thyroid Eye Disease

Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2026-07-14

Participants Needed

Research Sites

28 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and tolerability of IBI3031, a bispecific antibody targeting IGF-1R and TSHR, in people with Thyroid Eye Disease TED. This first-in-human Phase 1 trial focuses on Chinese participants and aims to study how the drug behaves in the body, its immune response, and its potential effects on TED and thyroid function. The study involves a randomized, double-masked, placebo-controlled design to carefully assess these factors. The trial has two main stages Stage 1 involves a single ascending dose SAD where participants receive one dose of IBI3031 or placebo by subcutaneous injection or intravenous infusion. Stage 2 is a multiple ascending dose MAD phase where participants receive three subcutaneous doses of IBI3031 or placebo to evaluate safety, tolerability, and steady-state drug levels. About 66 participants will be enrolled, with 36 in Stage 1 and 30 in Stage 2, assigned to treatment or placebo groups. Participants will undergo regular monitoring for side effects and lab changes up to Day 85 for the single-dose phase and Day 337 for the multiple-dose phase. Assessments include physical exams, blood pressure, heart rate, blood tests, thyroid function, ECGs, hearing tests, and quality of life questionnaires. Researchers will also measure drug levels and immune responses over time. The study lasts until December 2027, with close safety and efficacy evaluations throughout the treatment periods.

CONDITIONS

Brief Title

A Study of IBI3031 in Participants With Thyroid Eye Disease

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Written informed consent.
Age between 18 and 75 years at screening.
Weight between 45 kg and 100 kg.
Moderate-to-severe active Thyroid Eye Disease with Clinical Activity Score (CAS) of 3 or higher in the study eye at screening and baseline.
Presence of at least two signs: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, or inconstant/constant diplopia.
Onset of active TED symptoms within 12 months prior to screening.
Exophthalmos ≥ 18 mm in the study eye at baseline (Stage 2 only).
Clinically and biochemically euthyroid, or mild hypothyroidism or mild-to-moderate hyperthyroidism at screening.
Positive Thyrotrophin Receptor Antibody (TRAb) at screening.
No prior antithyroid or thyroid hormone therapy, or stable dose for at least 6 weeks before first dose, or intolerant to such therapy for at least 6 weeks before first dose.
Infertile female participants or fertile females with negative pregnancy test and agreement to contraception from screening to 120 days after last dose; males agreeing to contraception for same period.

You will not qualify if you...

Reduction in CAS of study eye by 2 or more points or proptosis reduced by 2 or more mm from screening to baseline.
Diagnosis or suspicion of dysthyroid optic neuropathy (DON).
Corneal ulcers not relieved by treatment.
Other non-TED eye diseases affecting study results or safety.
Significant hypothyroidism or severe hyperthyroidism at screening.
History of significant liver disease, abnormal liver enzymes, low kidney function, poorly controlled diabetes or hypertension, inflammatory bowel disease, gastrointestinal bleeding, or peptic ulcer disease.
History of chronic or recent infections, positive HIV, hepatitis, syphilis tests, or tuberculosis screening.
History of hearing impairment or abnormal hearing test results.
Scheduled radioactive iodine therapy, thyroidectomy, orbital radiotherapy, or TED surgery before or during study.
Recent high-dose glucocorticoid use or immunosuppressants within specified timeframes.
Use of glucocorticoid or immunosuppressant eye drops shortly before screening.
Prior antibody therapy targeting IGF-1R, TSHR, CD20, IL-6 or IL-6 receptor.
Use of other TED experimental drugs or monoclonal antibodies recently.
Receipt of live vaccines within 180 days before screening or planned during study.
Pregnancy or lactation in female participants.

Research Team

Zhongyan shan

funan liu

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Phase I Study to Assess Safety and Dosage of IBI3031 in Adults with Thyroid Eye Disease

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria