Loading clinical trials...

Study of ZB001 in Chinese Patients With Thyroid Eye Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of ZB001 in Chinese Patients With Thyroid Eye Disease

A Multiple Ascending Doses Study of ZB001 in Chinese Patients With Thyroid-Associated Ophthalmopathy

NCT05776121•Zenas BioPharma (USA), LLC

Summary

The investigational drug, ZB001 is a humanized IgG1κ monoclonal antibody targeting human IGF-1R. The study is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetics（PK）/pharmacodynamics (PD) profile of ZB001 in Chinese patients with Thyroid Eye Disease.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female adults, 18 years of age or older
•2. Clinical diagnosis of Graves' ophthalmopathy and CAS evaluation of eyes under study ≥ 4 points (7 points in total)
•3. Moderate-to-severe active thyroid-associated ophthalmopathy (i.e., severely affects daily life): exophthalmos extent is ≥18.6 mm, or progressive exophthalmos (≥3 mm greater than the previous exophthalmos record per the investigator); accompanied by at least one of the following symptoms: eyelid retraction ≥ 2 mm; moderate or severe soft tissue involvement (conjunctival congestion, edema, periorbital congestion or edema); non-persistent or persistent diplopia
•4. Before Screening, evidence of eye symptoms or signs related to thyroid-associated ophthalmopathy in medical records for ≤1 year
•5. Thyroid function normal, or only mild hyperthyroidism or hypothyroidism, defined as free thyroxine (FT4) ）and free triiodothyronine (FT3) levels within 0.5-1.5 times the normal range at Screening. Efforts have been made to correct any mild hypothyroidism or hyperthyroidism in a timely manner and try to maintain normal thyroid function throughout the study. Thyroidectomy is not an exclusion.
•6. If the patient is a female of childbearing potential (including a female with menopause \< 1 year, amenorrhea \< 1 year, or without surgical sterilization), the pregnancy test result will be negative at Screening. Such patients must agree to use the effective birth control methods described in the relevant protocol section (Section 9.2 Contraception and Pregnancy) at least one complete menstrual cycle before the first dose of the study drug, and continue to use contraception methods for 100 days after the last dose
•7. Male patients must be surgically sterilized for at least 6 weeks or agree to use the effective birth control methods described in the relevant protocol section (Section 9.2 Contraception and Pregnancy) before the first dose of the study drug and within 100 days after the last dose

Exclusion Criteria

•1. In the past 6 months, due to optic neuropathy, new visual field defect or color defect secondary to optic nerve involvement, the best corrected visual acuity of the study eye decreased, defined as the result of standardized visual acuity chart decreased ≥ 0.2
•2. Corneal involvement of the study eye, and no improvement after medical interventions
•3. CAS decreased ≥ 2 points from Screening Assessment to Day -1
•4. The exophthalmos extent of the study eye ≥ 2 mm from Screening Assessment to Day -1
•5. The study eye previously received orbital radiotherapy or surgery due to thyroid-associated ophthalmopathy
•6. Known history of clinically significant ear disease, ear surgery or hearing loss
•7. Inflammatory bowel disease (e.g., biopsy-proven or clinical evidence of inflammatory bowel disease)
•8. Cumulative use of glucocorticoid equivalent to ≥ 1g methylprednisolone as thyroid-associated ophthalmopathy treatment (A lower cumulative dose \[\<1g\] of glucocorticoid used before Screening, or hormone eye drops withdrawn for ≥ 6 weeks before Screening, is allowed for inclusion)
•9. Received any doses of oral corticosteroids to treat diseases other than thyroid-associated ophthalmopathy within 4 weeks before Screening (local application is allowed for inclusion)
•10. Pregnant or lactating females
+2 more criteria

Locations (9)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Beijing Tongren Hospital, CMU

Beijing, China

Peking University Third Hospital

Beijing, China

Third Xiangya Hospital of Central South University

Changsha, China

Xiangya Hospital Central South University

Changsha, China

Chongqing Aier General Hospital

Chongqing, China

The Second Hosptial of Dalian Medical University

Dalian, China

The Second Hosptial of Anhui Medical University

Hefei, China

Affiliated Eye Hospital of Nanchang University

Nanchang, China

Key Dates

Start Date

May 10, 2023

Primary Completion Date

April 17, 2024

Completion Date

April 17, 2024

Last Updated

April 11, 2025

Enrollment

ACTUAL participants

Conditions

Thyroid Eye Disease

Interventions

ZB001 for injection

DRUG

ZB001 for injection

DRUG

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

NCT06112340

Thyroid Eye DiseaseGraves Orbitopathy+10 more

View study

RECRUITINGNA

Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease

NCT06359795

Thyroid Eye Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of ZB001 in Chinese Patients With Thyroid Eye Disease

Inclusion Criteria

Exclusion Criteria

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease

Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting

A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease

A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)