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ZB001

Phase 1

Thyroid Eye Disease | Small molecule | Endocrine |Zenas BioPharma, Inc.|Trials Updated: Apr 11, 2025

ZB001 target and mechanism

ModalitySmall molecule

Also known as ZB001 for injection

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

ZB001 clinical trials

ZB001 · 1 trial · 1 indication

Phase 1 1
NCT05776121Study of ZB001 in Chinese Patients With Thyroid Eye DiseaseThyroid Eye Disease
COMPLETED17 Analytics
PHASE1COMPLETED
Study of ZB001 in Chinese Patients With Thyroid Eye Disease
Thyroid Eye DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ZB001 for injectionEXPERIMENTALTreat different dose cohorts with four intravenous injections of ZB001

Interventions

NameTypeDescription
ZB001 for injectionDRUGDose Cohort1 (3 mg/kg) ZB001 four IV injections
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

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): exophthalm...

Countries:China
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Frequently asked questions about ZB001

What is ZB001?

ZB001 is an investigational small molecule being developed by Zenas BioPharma, Inc. for the treatment of thyroid eye disease, an endocrine condition. It is in Phase 1 clinical development and has been studied in a completed Phase 1 trial in Chinese patients. ZB001 is also known as ZB001 for injection.

What is ZB001 used for in thyroid eye disease?

ZB001 is being developed as a treatment for thyroid eye disease, an endocrine condition affecting the tissues around the eyes. It is an investigational small molecule in Phase 1 development. Zenas BioPharma, Inc. is evaluating ZB001 for this indication, and a Phase 1 study in Chinese patients has been completed.

Who makes ZB001?

ZB001 is being developed by Zenas BioPharma, Inc., which trades under the ticker ZBIO. The company is advancing ZB001 as an investigational small molecule for thyroid eye disease. Zenas BioPharma conducted a completed Phase 1 trial of ZB001 in Chinese patients with thyroid eye disease.

What phase is ZB001 in?

ZB001 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved for any indication. One Phase 1 trial of ZB001 has been completed, and no active trials are currently listed. The completed study enrolled 17 patients with thyroid eye disease in China.

What clinical trials is ZB001 in?

ZB001 has been studied in one completed Phase 1 trial, NCT05776121, titled Study of ZB001 in Chinese Patients With Thyroid Eye Disease. The trial enrolled 17 patients in China, was uncontrolled, and was not randomized or double blinded. No active trials of ZB001 are currently listed.

Is ZB001 the same as ZB001 for injection?

Yes, ZB001 for injection is another name for ZB001. Both refer to the same investigational small molecule developed by Zenas BioPharma, Inc. for thyroid eye disease. ZB001 is in Phase 1 development and has completed one Phase 1 trial in Chinese patients.