Thyroid Eye DiseasePhase 1NCT07622368
A Study of IBI3031 in Participants With Thyroid Eye Disease
A Phase 1 study testing IBI3031 in people with Thyroid Eye Disease, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- IBI3031
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 28 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Aged between 18 and 75 years at screening.
- Weight between 45 kg and 100 kg.
- Moderate-to-severe active TED:
- CAS ≥ 3 in the study eye at screening and baseline;
- Usually associated with at least two of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, and/or inconstant or constant diplopia;
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- ≤ 12 months since the onset of active TED symptoms according to subjects' chief complaint or medical record at screening;
- 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.
- Infertile female participants or fertile female participants with negative blood pregnancy test results during the screening period and agree to take contraceptive measures from screening to 120 days after the last dose; male participants should agree to use contraceptive measures from screening to 120 days after the last dose.
Who cannot join
- Participants to be excluded (Participants meeting any of the following criteria will be regarded as ineligible):
- 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;
- 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).
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- 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:
- History of hepatic insufficiency (Child-Pugh Class B or C) or liver cirrhosis; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 × ULN at screening;
- Glomerular filtration rate (GFR) < 60 ml/min/1.73 m2;
- Poorly controlled diabetes mellitus or hypertension;
- Confirmed or clinically suspected inflammatory bowel disease, gastrointestinal bleeding, or peptic ulcer disease.
- History of of chronic or recurrent infections; opportunistic infection within 180 days prior to screening;
- Positive for human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), non-specific syphilis antibody (e.g., RPR(Rapid Plasma Reagin), TRUST), hepatitis B virus surface antigen (HBsAg) or e-antigen (HBeAg), or interferon-gamma release assay (IGRA).
- History of tinnitus or other hearing impairment in either ear during the screening period; or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥ 25 dB(decibe) at 0.5, 1, 2, and 4 kHz(kilohertz), or a bone conduction hearing threshold of ≥ 40 dB at any frequency);
- 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;
- Cumulative dose of glucocorticoids used to treat TED ≥ 1 g of methylprednisolone equivalents within 90 days prior to screening;
- Oral or intravenous glucocorticoids within 30 days prior to screening;
- Peribulbar/periorbital injection of glucocorticoids within 90 days prior to screening;
- Oral or intravenous administration of any other non-steroidal immunosuppressants within 90 days prior to screening;
- Use of glucocorticoid eye drops/ointments or use of non-steroidal immunosuppressant eye drops within 14 days prior to screening;
- Received antibody therapy targeting IGF-1R, TSHR, CD20(cluster of differentiation antigen 20), IL-6, or IL-6 receptor (IL-6R) at any time before screening;
- Received any other TED therapeutic drugs under development (including but not limited to biologics targeting IGF-1R, FcRn(neonatal Fc recepto), IL-6, or IL-6R) at any time before screening;
- Use of any other monoclonal antibody within 90 days prior to screening;
- Have received live vaccines within 180 days prior to screening, or plan to receive live vaccines during the study;
- Female participants in pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
Zhongyan Dan, 02483282152, shanzhongyan@hotmail.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of IBI3031 in Participants With Thyroid Eye Disease
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.
Read the detailed description
IBI3031 is an IGF-1R(Insulin-like growth factor 1 receptor)/TSHR(Thyroid-stimulating hormone receptor) bispecific antibody with potential synergistic therapeutic efficacy in TED and modulatory effects on thyroid function. As the first-in-human trial of IBI3031, this study evaluates the safety, tolerability, PK(Pharmacokinetics)/PD(Pharmacodynamics) profiles, immunogenicity, and efficacy of IBI3031 in TED participants. The trial is conducted in two stages: Stage 1- a single-ascending-dose (SAD) study involving single SC or IV administration of IBI3031; Stage 2- a multiple-ascending-dose (MAD) study involving three SC administrations of IBI3031. Approximately 66 TED participants are planned for enrollment: 36 in Stage 1 (allocated at a 3:1 ratio) and 30 in Stage 2 (allocated at a 4:1 ratio).
- Conditions
- Thyroid Eye Disease
- Being tested
- IBI3031, placebo
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3031Drug
subcutaneous injection or intravenous infusion.
placeboDrug
subcutaneous injection or intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| SAD Dose 4 - Placebo Control Group | Placebo comparator | Subjects receive matching placebo to the treatment group. Receives: Drug: placebo |
| MAD Dose 2- IBI3031A101 Treatment Group | Experimental | Multiple ascending dose (MAD) phase. Subjects receive repeated doses of IBI3031A101 to evaluate safety, tolerability and steady-state pharmacokinetics. Receives: Drug: IBI3031 |
| SAD Dose 4 - IBI3031A101 Treatment Group | Experimental | Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics. Receives: Drug: IBI3031 |
| MAD Dose 1 - Placebo Control Group | Placebo comparator | Multiple ascending dose (MAD) phase. Subjects receive matching placebo to the treatment group. Receives: Drug: placebo |
| MAD Dose 1- IBI3031A101 Treatment Group | Experimental | Multiple ascending dose (MAD) phase. Subjects receive repeated doses of IBI3031A101 to evaluate safety, tolerability and steady-state pharmacokinetics. Receives: Drug: IBI3031 |
| MAD Dose 3 - Placebo Control Group | Placebo comparator | Multiple ascending dose (MAD) phase. Subjects receive matching placebo to the treatment group. Receives: Drug: placebo |
| SAD Dose 5 - IBI3031A101 Treatment Group | Experimental | Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics. Receives: Drug: IBI3031 |
| MAD Dose 2 - Placebo Control Group | Placebo comparator | Multiple ascending dose (MAD) phase. Subjects receive matching placebo to the treatment group. Receives: Drug: placebo |
| SAD - Dose 1 - Placebo Control Group | Placebo comparator | Subjects receive matching placebo to the treatment group. Receives: Drug: placebo |
| SAD Dose 3 - IBI3031A101 Treatment Group | Experimental | Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics.(at the same dose level as Arm 2 but via [different route/method) Receives: Drug: IBI3031 |
| SAD Dose 2 - IBI3031A101 Treatment Group | Experimental | Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics. Receives: Drug: IBI3031 |
| SAD Dose 5 - Placebo Control Group | Placebo comparator | Subjects receive matching placebo to the treatment group. Receives: Drug: placebo |
| SAD Dose 3 - Placebo Control Group | Placebo comparator | Subjects receive matching placebo to the treatment group. Receives: Drug: placebo |
| MAD Dose 3- IBI3031A101 Treatment Group | Experimental | Multiple ascending dose (MAD) phase. Subjects receive repeated doses of IBI3031A101 to evaluate safety, tolerability and steady-state pharmacokinetics. Receives: Drug: IBI3031 |
| SAD - Dose 2 - Placebo Control Group | Placebo comparator | Subjects receive matching placebo to the treatment group. Receives: Drug: placebo |
| SAD Dose 1 - IBI3031A101 Treatment Group | Experimental | Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics. Receives: Drug: IBI3031 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number, incidence rate, severity, and association with the study drug of Adverse Events (AEs)
The number, incidence rate, severity, and association with the study drug of all AEs occurring throughout the trial will be summarized.
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Number, incidence rate, severity, and association with the study drug of Treatment-Emergent Adverse Events (TEAEs)
The number, incidence rate, severity, and association with the study drug of all TEAEs after study drug administration will be summarized.
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Number, incidence rate, severity, and association with the study drug of Serious Adverse Events (SAEs)
The number, incidence rate, severity, and association with the study drug of all SAEs will be summarized.
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Change in systolic and diastolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)
Systolic and diastolic blood pressure will be measured and recorded at each specified time point
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Number of participants with clinically significant abnormal findings in complete physical examination(Unit of Measure: participants)
A complete physical examination will be performed at each specified time point, including assessment of general appearance, respiratory system, cardiovascular system, abdomen, skin, head and neck (including ears, nose, and throat), lymph nodes, thyroid gland, musculoskeletal system (including spine and extremities), and neurological system. Any finding that is new or worsened from baseline and deemed clinically significant by the investigator will be
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Changes in hematology laboratory parameters before and after dosing in each dose group
Changes in hematology parameters including white blood cell count, red blood cell count, hemoglobin, and platelet count will be recorded.
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Changes in blood chemistry laboratory parameters before and after dosing in each dose group
Changes in blood chemistry parameters including liver and renal function, electrolytes, and blood glucose will be recorded.
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Changes in urinalysis laboratory parameters before and after dosing in each dose group
Changes in urinalysis parameters including urine protein, urine occult blood, and urine leukocytes will be recorded.
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Changes in thyroid function laboratory parameters before and after dosing in each dose group
Changes in thyroid function parameters including thyroid-stimulating hormone, free triiodothyronine, and free thyroxine will be recorded.
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Number of subjects with abnormal ECG changes before and after administration in each dose group
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Changes in pure-tone audiometry results before and after dosing in each dose group
Changes in hearing thresholds at each frequency (500 Hz, 1000 Hz, 2000 Hz, 4000 Hz) will be recorded.
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Change in heart rate after dosing in each dose group (Unit of Measure: beats per minute)
Heart rate will be measured and recorded at each specified time point.
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Change in body temperature after dosing in each dose group(Unit of Measure: °C)
Body temperature will be measured and recorded at each specified time point.
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Change in respiratory rate after dosing in each dose group( Unit of Measure: breaths per minute)
Respiratory rate will be measured and recorded at each specified time point.
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Secondary outcomes (13)
Area Under the Curve (AUC) of the serum concentration-time profile
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Maximum Concentration (Cmax) of the drug in serum
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Clearance (CL)
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Volume of Distribution (Vd)
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Elimination Half-life (t1/2)
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Production of anti-drug antibodies (ADAs) and/or neutralizing antibodies (NAbs) in serum
Measured: up to Day 85 for SAD;up to Day 337 for MAD
Proportion of participants with proptosis response
Defined as a ≥2 mm reduction in proptosis in the study eye from baseline, without a ≥2 mm increase in proptosis in the fellow eye
Measured: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
Proportion of participants with overall response
Defined as a ≥2-point reduction in the Clinical Activity Score (CAS) from baseline in the study eye, a ≥2 mm reduction in proptosis in the study eye from baseline, and no worsening in the fellow eye (worsening defined as a ≥2-point increase in CAS or a ≥2 mm increase in proptosis)
Measured: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
Number of subjects with changes in proptosis from baseline after dosing
Measured: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
Proportion of participants with CAS = 0 or 1
Measured: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
CAS change from baseline
Measured: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
Proportion of participants with diplopia response
Defined as a ≥1-point reduction in diplopia
Measured: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
Total score of the Graves' Ophthalmopathy Quality of Life
The effect of thyroid eye disease on social activities and appearance during the past 1 week.
Measured: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start30 Jun 2026
- Primary completion15 Jun 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622368
- Sponsor's protocol ID
- CIBI3031A101
- Status last verified
- Jul 2026
- First submitted
- 19 May 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of IBI3031 in Participants With Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT07622368
- Acronym / sponsor ID
- CIBI3031A101
- Conditions
- Thyroid Eye Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
IBI3031 is an IGF-1R(Insulin-like growth factor 1 receptor)/TSHR(Thyroid-stimulating hormone receptor) bispecific antibody with potential synergistic therapeutic efficacy in TED and modulatory effects on thyroid function. As the first-in-human trial of IBI3031, this study evaluates the safety, tolerability, PK(Pharmacokinetics)/PD(Pharmacodynamics) profiles, immunogenicity, and efficacy of IBI3031 in TED participants. The trial is conducted in two stages: Stage 1- a single-ascending-dose (SAD) study involving single SC or IV administration of IBI3031; Stage 2- a multiple-ascending-dose (MAD) study involving three SC administrations of IBI3031. Approximately 66 TED participants are planned for enrollment: 36 in Stage 1 (allocated at a 3:1 ratio) and 30 in Stage 2 (allocated at a 4:1 ratio).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| SAD Dose 4 - Placebo Control Group | Placebo comparator | Drug: placeboSubjects receive matching placebo to the treatment group. |
| MAD Dose 2- IBI3031A101 Treatment Group | Experimental | Drug: IBI3031Multiple ascending dose (MAD) phase. Subjects receive repeated doses of IBI3031A101 to evaluate safety, tolerability and steady-state pharmacokinetics. |
| SAD Dose 4 - IBI3031A101 Treatment Group | Experimental | Drug: IBI3031Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics. |
| MAD Dose 1 - Placebo Control Group | Placebo comparator | Drug: placeboMultiple ascending dose (MAD) phase. Subjects receive matching placebo to the treatment group. |
| MAD Dose 1- IBI3031A101 Treatment Group | Experimental | Drug: IBI3031Multiple ascending dose (MAD) phase. Subjects receive repeated doses of IBI3031A101 to evaluate safety, tolerability and steady-state pharmacokinetics. |
| MAD Dose 3 - Placebo Control Group | Placebo comparator | Drug: placeboMultiple ascending dose (MAD) phase. Subjects receive matching placebo to the treatment group. |
| SAD Dose 5 - IBI3031A101 Treatment Group | Experimental | Drug: IBI3031Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics. |
| MAD Dose 2 - Placebo Control Group | Placebo comparator | Drug: placeboMultiple ascending dose (MAD) phase. Subjects receive matching placebo to the treatment group. |
| SAD - Dose 1 - Placebo Control Group | Placebo comparator | Drug: placeboSubjects receive matching placebo to the treatment group. |
| SAD Dose 3 - IBI3031A101 Treatment Group | Experimental | Drug: IBI3031Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics.(at the same dose level as Arm 2 but via [different route/method) |
| SAD Dose 2 - IBI3031A101 Treatment Group | Experimental | Drug: IBI3031Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics. |
| SAD Dose 5 - Placebo Control Group | Placebo comparator | Drug: placeboSubjects receive matching placebo to the treatment group. |
| SAD Dose 3 - Placebo Control Group | Placebo comparator | Drug: placeboSubjects receive matching placebo to the treatment group. |
| MAD Dose 3- IBI3031A101 Treatment Group | Experimental | Drug: IBI3031Multiple ascending dose (MAD) phase. Subjects receive repeated doses of IBI3031A101 to evaluate safety, tolerability and steady-state pharmacokinetics. |
| SAD - Dose 2 - Placebo Control Group | Placebo comparator | Drug: placeboSubjects receive matching placebo to the treatment group. |
| SAD Dose 1 - IBI3031A101 Treatment Group | Experimental | Drug: IBI3031Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (26 listed)
- Participants to be excluded (Participants meeting any of the following criteria will be regarded as ineligible):
- 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;
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI3031subcutaneous injection or intravenous infusion. | Drug | MAD Dose 1- IBI3031A101 Treatment Group, MAD Dose 2- IBI3031A101 Treatment Group, MAD Dose 3- IBI3031A101 Treatment Group, SAD Dose 1 - IBI3031A101 Treatment Group, SAD Dose 2 - IBI3031A101 Treatment Group, SAD Dose 3 - IBI3031A101 Treatment Group, SAD Dose 4 - IBI3031A101 Treatment Group, SAD Dose 5 - IBI3031A101 Treatment Group |
| placebosubcutaneous injection or intravenous infusion. | Drug | MAD Dose 1 - Placebo Control Group, MAD Dose 2 - Placebo Control Group, MAD Dose 3 - Placebo Control Group, SAD - Dose 1 - Placebo Control Group, SAD - Dose 2 - Placebo Control Group, SAD Dose 3 - Placebo Control Group, SAD Dose 4 - Placebo Control Group, SAD Dose 5 - Placebo Control Group |
Primary outcome
Number, incidence rate, severity, and association with the study drug of Adverse Events (AEs)
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
The number, incidence rate, severity, and association with the study drug of all AEs occurring throughout the trial will be summarized.
Number, incidence rate, severity, and association with the study drug of Treatment-Emergent Adverse Events (TEAEs)
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
The number, incidence rate, severity, and association with the study drug of all TEAEs after study drug administration will be summarized.
Number, incidence rate, severity, and association with the study drug of Serious Adverse Events (SAEs)
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
The number, incidence rate, severity, and association with the study drug of all SAEs will be summarized.
Change in systolic and diastolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Systolic and diastolic blood pressure will be measured and recorded at each specified time point
Number of participants with clinically significant abnormal findings in complete physical examination(Unit of Measure: participants)
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
A complete physical examination will be performed at each specified time point, including assessment of general appearance, respiratory system, cardiovascular system, abdomen, skin, head and neck (including ears, nose, and throat), lymph nodes, thyroid gland, musculoskeletal system (including spine and extremities), and neurological system. Any finding that is new or worsened from baseline and deemed clinically significant by the investigator will be
Changes in hematology laboratory parameters before and after dosing in each dose group
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Changes in hematology parameters including white blood cell count, red blood cell count, hemoglobin, and platelet count will be recorded.
Changes in blood chemistry laboratory parameters before and after dosing in each dose group
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Changes in blood chemistry parameters including liver and renal function, electrolytes, and blood glucose will be recorded.
Changes in urinalysis laboratory parameters before and after dosing in each dose group
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Changes in urinalysis parameters including urine protein, urine occult blood, and urine leukocytes will be recorded.
Changes in thyroid function laboratory parameters before and after dosing in each dose group
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Changes in thyroid function parameters including thyroid-stimulating hormone, free triiodothyronine, and free thyroxine will be recorded.
Number of subjects with abnormal ECG changes before and after administration in each dose group
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Changes in pure-tone audiometry results before and after dosing in each dose group
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Changes in hearing thresholds at each frequency (500 Hz, 1000 Hz, 2000 Hz, 4000 Hz) will be recorded.
Change in heart rate after dosing in each dose group (Unit of Measure: beats per minute)
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Heart rate will be measured and recorded at each specified time point.
Change in body temperature after dosing in each dose group(Unit of Measure: °C)
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Body temperature will be measured and recorded at each specified time point.
Change in respiratory rate after dosing in each dose group( Unit of Measure: breaths per minute)
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Respiratory rate will be measured and recorded at each specified time point.
13 secondary outcomes
Area Under the Curve (AUC) of the serum concentration-time profile
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Maximum Concentration (Cmax) of the drug in serum
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Clearance (CL)
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Volume of Distribution (Vd)
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Elimination Half-life (t1/2)
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Production of anti-drug antibodies (ADAs) and/or neutralizing antibodies (NAbs) in serum
Time frame: up to Day 85 for SAD;up to Day 337 for MAD
Proportion of participants with proptosis response
Time frame: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
Proportion of participants with overall response
Time frame: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
Number of subjects with changes in proptosis from baseline after dosing
Time frame: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
Proportion of participants with CAS = 0 or 1
Time frame: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
CAS change from baseline
Time frame: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
Proportion of participants with diplopia response
Time frame: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
Total score of the Graves' Ophthalmopathy Quality of Life
Time frame: Day 8, Day 29, Day 57, and Day 85 for single ascending dose (SAD) stage; Week 5, Week 9, Week 13, Week 17, Week 21, Week 29, Week 37, and Week 49 for multiple ascending dose (MAD) stage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI3031 in people with Thyroid Eye Disease, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongyan shan (024-83282152, Shanzhongyan@medmal.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number, incidence rate, severity, and association with the study drug of Adverse Events (AEs) (time frame: up to Day 85 for SAD;up to Day 337 for MAD). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.