Study of ZB001 in Chinese Patients With Thyroid Eye Disease

NCT ID: NCT05776121

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2024-04-17

Brief 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.

Conditions

Thyroid Eye Disease

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZB001 for injection

Treat different dose cohorts with four intravenous injections of ZB001

Group Type: EXPERIMENTAL

ZB001 for injection

Intervention Type: DRUG

Dose Cohort1 (3 mg/kg) ZB001 four IV injections

ZB001 for injection

Intervention Type: DRUG

Dose Cohort2 (10 mg/kg) ZB001 four IV injections

Interventions

ZB001 for injection

Dose Cohort1 (3 mg/kg) ZB001 four IV injections

Intervention Type: DRUG

ZB001 for injection

Dose Cohort2 (10 mg/kg) ZB001 four IV injections

Intervention Type: DRUG

Eligibility Criteria

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

11. Smokers (≥ 5 cigarettes/day) or former smokers (≥ 5 cigarettes/day) quit within 6 months before enrollment in the study

12. Any vaccination planned during the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zenas BioPharma (USA), LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

China

Other Identifiers

ZB001-01-002

Identifier Type: -

Identifier Source: org_study_id