Study of ZB001 in Chinese Patients With Thyroid Eye Disease

NCT05776121 | Completed Phase 1 DMC

• 1 other identifier: ZB001-01-002
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 9

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with Adverse Events, Serious Adverse Events, and Laboratory Evaluations as assessed by CTCAE v5.0

  through study completion, up to 169 days

• The exophthalmos response rates of study eye at Week 6 and Week 12 (defined as the proportion of patients whose exophthalmos measured by Hertel exophthalmos meter decreased ≥ 2mm from baseline)

  At week6 and week 12

Secondary Outcomes (24)

• Change from baseline in the study eye at Week 6, Week 12 and Week 24 of Exophthalmos measured by MRI/CT scan

  At week6, week 12 and week 24

• Change from baseline in the study eye at Week 6, Week 12 and Week 24 of Orbital fat volume measured by MRI/CT scan

  At week6, week 12 and week 24

• Change from baseline in the study eye at Week 6, Week 12 and Week 24 of Extraocular eye muscle volume measured by MRI/CT scan

  At week6, week 12 and week24

• Change from baseline in the study eye at Week 6, Week 12 and Week 24 of Facial fat volume measured by MRI/CT scan

  At week6, week 12 and week 24

• Change from baseline in the study eye at Week 6, Week 12 and Week 24 of Digital and manual measurement of palpebral fissure height

  At week6, week 12 and week 24

Study Arms (1)

ZB001 for injection

EXPERIMENTAL

Treat different dose cohorts with four intravenous injections of ZB001

Drug: ZB001 for injection

Interventions

ZB001 for injection DRUG

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

ZB001 for injection

Eligibility Criteria

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

You may qualify if:

• Male or female adults, 18 years of age or older
• Clinical diagnosis of Graves' ophthalmopathy and CAS evaluation of eyes under study ≥ 4 points (7 points in total)
• 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
• Before Screening, evidence of eye symptoms or signs related to thyroid-associated ophthalmopathy in medical records for ≤1 year
• 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
• 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

You may not qualify if:

• 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
• Corneal involvement of the study eye, and no improvement after medical interventions
• CAS decreased ≥ 2 points from Screening Assessment to Day -1
• The exophthalmos extent of the study eye ≥ 2 mm from Screening Assessment to Day -1
• The study eye previously received orbital radiotherapy or surgery due to thyroid-associated ophthalmopathy
• Known history of clinically significant ear disease, ear surgery or hearing loss
• Inflammatory bowel disease (e.g., biopsy-proven or clinical evidence of inflammatory bowel disease)
• Pregnant or lactating females
• Smokers (≥ 5 cigarettes/day) or former smokers (≥ 5 cigarettes/day) quit within 6 months before enrollment in the study
• Any vaccination planned during the study

Sponsors & Collaborators

• Zenas BioPharma (USA), LLC: lead

Study Sites (9)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing Tongren Hospital, CMU

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

Third Xiangya Hospital of Central South University

Changsha, China

Location

Xiangya Hospital Central South University

Changsha, China

Location

Chongqing Aier General Hospital

Chongqing, China

Location

The Second Hosptial of Dalian Medical University

Dalian, China

Location

The Second Hosptial of Anhui Medical University

Hefei, China

Location

Affiliated Eye Hospital of Nanchang University

Nanchang, China

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Injections

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 20, 2023
• Study Start: May 10, 2023
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

CN (9)