A Study of IBI3031 in Participants With Thyroid Eye Disease

NCT07622368 | Not Yet Recruiting Phase 1

• 1 other identifier: CIBI3031A101
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Eye Disease

Outcome Measures

Primary Outcomes (14)

• 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.

  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.

  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.

  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

  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

  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.

  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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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

  up to Day 85 for SAD;up to Day 337 for MAD

• Maximum Concentration (Cmax) of the drug in serum

  up to Day 85 for SAD;up to Day 337 for MAD

• Clearance (CL)

  up to Day 85 for SAD;up to Day 337 for MAD

• Volume of Distribution (Vd)

  up to Day 85 for SAD;up to Day 337 for MAD

• Elimination Half-life (t1/2)

  up to Day 85 for SAD;up to Day 337 for MAD

Study Arms (16)

SAD Dose 4 - Placebo Control Group

PLACEBO COMPARATOR

Subjects receive matching placebo to the treatment group.

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.

Drug: IBI3031

SAD Dose 4 - IBI3031A101 Treatment Group

EXPERIMENTAL

Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics.

Drug: IBI3031

MAD Dose 1 - Placebo Control Group

PLACEBO COMPARATOR

Multiple ascending dose (MAD) phase. Subjects receive matching placebo to the treatment group.

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.

Drug: IBI3031

MAD Dose 3 - Placebo Control Group

PLACEBO COMPARATOR

Multiple ascending dose (MAD) phase. Subjects receive matching placebo to the treatment group.

Drug: placebo

SAD Dose 5 - IBI3031A101 Treatment Group

EXPERIMENTAL

Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics.

Drug: IBI3031

MAD Dose 2 - Placebo Control Group

PLACEBO COMPARATOR

Multiple ascending dose (MAD) phase. Subjects receive matching placebo to the treatment group.

Drug: placebo

SAD - Dose 1 - Placebo Control Group

PLACEBO COMPARATOR

Subjects receive matching placebo to the treatment group.

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)

Drug: IBI3031

SAD Dose 2 - IBI3031A101 Treatment Group

EXPERIMENTAL

Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics.

Drug: IBI3031

SAD Dose 5 - Placebo Control Group

PLACEBO COMPARATOR

Subjects receive matching placebo to the treatment group.

Drug: placebo

SAD Dose 3 - Placebo Control Group

PLACEBO COMPARATOR

Subjects receive matching placebo to the treatment group.

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.

Drug: IBI3031

SAD - Dose 2 - Placebo Control Group

PLACEBO COMPARATOR

Subjects receive matching placebo to the treatment group.

Drug: placebo

SAD Dose 1 - IBI3031A101 Treatment Group

EXPERIMENTAL

Subjects receive single-dose IBI3031A101 at different dose levels to evaluate safety, tolerability and pharmacokinetics.

Drug: IBI3031

Interventions

IBI3031 DRUG

subcutaneous injection or intravenous infusion.

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

placebo DRUG

subcutaneous injection or intravenous infusion.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ≤ 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.

You may not qualify if:

• 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).
• 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;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Zhongyan shan

CONTACT

024-83282152; Shanzhongyan@medmal.com.cn

funan liu

CONTACT

024-83281137; lfn540@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 3, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 28, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

CN (1)