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ZB001

Phase 1

Healthy Volunteers | Small molecule | Other |Zenas BioPharma, Inc.|Last Updated: Apr 11, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

ZB001 · 2 trials · 2 indications

Phase 1 2
NCT05776121Study of ZB001 in Chinese Patients With Thyroid Eye DiseaseThyroid Eye Disease
COMPLETED17 Analytics
NCT05542303A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy SubjectsHealthy Volunteers
COMPLETED24 Analytics
PHASE1COMPLETED
Study of ZB001 in Chinese Patients With Thyroid Eye Disease
Thyroid Eye Disease
NCT0577612117
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PHASE1COMPLETED
A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects
Healthy Volunteers
NCT0554230324
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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
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
during the study, up to 4 weeks

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 used for?

ZB001 is an investigational small molecule being studied for thyroid eye disease. It has completed Phase 1 trials in healthy volunteers and in Chinese patients with thyroid eye disease. The drug is still in clinical development and is not approved for any use.

Who makes ZB001?

ZB001 is being developed by Zenas BioPharma, Inc., a biopharmaceutical company. The company's stock trades under the ticker ZBIO. Zenas BioPharma is conducting clinical trials of ZB001 in China.

What phase is ZB001 in?

ZB001 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one in healthy volunteers and one in patients with thyroid eye disease. The drug is investigational and has not received regulatory approval.

What clinical trials is ZB001 in?

ZB001 has completed two Phase 1 trials. NCT05542303 was a safety, tolerability and pharmacokinetics study in 24 healthy subjects in China. NCT05776121 studied ZB001 in 17 Chinese patients with thyroid eye disease. Both trials are completed.

Is ZB001 the same as any other drug?

No alternative names for ZB001 have been disclosed. The drug is identified solely by its code name ZB001 in clinical trial records and by its developer, Zenas BioPharma.