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Study of ZB001 in Chinese Patients With Thyroid Eye Disease

NCT05776121 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-04-11

No results posted yet for this study

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

Interventions

DRUG

ZB001 for injection

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

DRUG

ZB001 for injection

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

Sponsors & Collaborators

  • Zenas BioPharma (USA), LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2024-04-17
Completion
2024-04-17

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05776121 on ClinicalTrials.gov