A Study of IBI3031 in Participants With Thyroid Eye Disease (NCT07622368) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of IBI3031 in Participants With Thyroid Eye Disease
China66 participantsStarted 2026-05-30
Plain-language summary
This is a multicenter, randomized, double-masked, placebo-controlled, single/multiple-dose-escalation trial conducted in Chinese participants with Thyroid Eye Disease (TED), aiming to evaluate the safety and tolerability of IBI3031 administered via subcutaneous or intravenous injection.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent.
. Aged between 18 and 75 years at screening.
. Weight between 45 kg and 100 kg.
. Moderate-to-severe active TED:
. Exophthalmos ≥ 18 mm in the study eye at baseline. (Only applicable to Stage 2)
. Participants must be clinically and biochemically euthyroid, or have mild hypothyroidism or mild-to-moderate hyperthyroidism at screening.
. Positive for Thyrotrophin Receptor Antibody (TRAb) at screening.
. No prior treatment with antithyroid medications and/or thyroid hormone replacement therapy, or having taken antithyroid medications and/or thyroid hormone replacement therapy on a stable dose for at least 6 weeks prior to the first dose, or having not been treated with antithyroid medications and/or thyroid hormone replacement therapy due to intolerable side effects for at least 6 weeks prior to the first dose.
Exclusion criteria
. The CAS of the study eye at baseline is reduced by ≥ 2 points compared with that at screening, or the proptosis of the study eye at baseline is reduced by ≥ 2 mm compared with that at screening;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number, incidence rate, severity, and association with the study drug of Adverse Events (AEs)
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
2
Number, incidence rate, severity, and association with the study drug of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
3
Number, incidence rate, severity, and association with the study drug of Serious Adverse Events (SAEs)
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
4
Change in systolic and diastolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
5
Number of participants with clinically significant abnormal findings in complete physical examination(Unit of Measure: participants)
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
6
Changes in hematology laboratory parameters before and after dosing in each dose group
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
. Participants previously diagnosed with dysthyroid optic neuropathy (DON), or with DON as determined by the investigator at screening;
. Patients with corneal ulcers that are not relieved after treatment at the investigator's discretion;
. Presence of other non-TED ophthalmic diseases that may affect the interpretation of study results or the safety of participants as determined by the investigator (e.g., proptosis not primarily caused by TED);
. At screening, clinical or laboratory evidence of significant hypothyroidism (presence of clinical symptoms of hypothyroidism, or FT3 or FT4 (Free Thyroxine)\<0.5×lower limit of normal \[LLN\], or TSH\>1.5×upper limit of normal \[ULN\]); or severe hyperthyroidism during the screening period (FT3 and FT4(Free Thyroxine)\>2×ULN, or presence of thyroid storm).
. Other medical history and abnormal test results during the screening period that are judged by the investigator to be clinically significant, may cause the participant to fail to comply with the study protocol or complete the trial, or endanger safety, including but not limited to:
. Scheduled radioactive iodine therapy or thyroidectomy at any time before screening or during the study;
. Scheduled orbital radiotherapy at any time before screening or during the study, or surgical treatment for TED, including orbital decompression, strabismus surgery, and eyelid surgery;
Changes in blood chemistry laboratory parameters before and after dosing in each dose group
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
8
Changes in urinalysis laboratory parameters before and after dosing in each dose group
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
9
Changes in thyroid function laboratory parameters before and after dosing in each dose group
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
10
Number of subjects with abnormal ECG changes before and after administration in each dose group
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
11
Changes in pure-tone audiometry results before and after dosing in each dose group
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
12
Change in heart rate after dosing in each dose group (Unit of Measure: beats per minute)
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
13
Change in body temperature after dosing in each dose group(Unit of Measure: °C)
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD
14
Change in respiratory rate after dosing in each dose group( Unit of Measure: breaths per minute)
Timeframe: up to Day 85 for SAD;up to Day 337 for MAD