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ZB004

Phase 1

Healthy Volunteers | Small molecule | Other |Zenas BioPharma, Inc.|Last Updated: Apr 13, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

ZB004 · 1 trial · 1 indication

Phase 1 1
NCT05794516A Safety and Pharmacokinetics Study of ZB004 in Healthy ParticipantsHealthy Volunteers
COMPLETED40 Analytics
PHASE1COMPLETED
A Safety and Pharmacokinetics Study of ZB004 in Healthy Participants
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Study Endpoints

Primary Endpoints

Number of participants with treatment-emergent adverse events (TEAEs) to evaluate Safety and Tolerability of ZB004
Day 1 through Day 99

Secondary Endpoints

Number of participants with treatment-emergent serious adverse events (SAEs)
Day 1 through Day 99
Number of participants with laboratory abnormalities
Day 1 through Day 99
Number of participants with Electrocardiogram (ECG) abnormalities
Day 1 through Day 99
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ZB004EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ZB004DRUGZB004 single doses administered subcutaneously as solution
PlaceboDRUGPlacebo single doses administered subcutaneously as solution
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female participants 18 to 55 years of age. * Body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants; body mass index of 18 to 35 kg/m\^2 for both male and female participants. * Considered in good health as determined by the Investigator....

Countries:New Zealand
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Frequently asked questions about ZB004

What is ZB004?

ZB004 is an investigational small molecule being developed by Zenas BioPharma, Inc. It is currently in Phase 1 clinical development. A completed Phase 1 study evaluated its safety and pharmacokinetics in healthy volunteers.

What is ZB004 used for?

ZB004 is being studied in healthy volunteers as part of early clinical development. The completed Phase 1 trial assessed its safety and pharmacokinetics in this population. Its intended therapeutic use has not been established.

Who makes ZB004?

ZB004 is being developed by Zenas BioPharma, Inc., a biopharmaceutical company. The company's stock trades under the ticker ZBIO.

What phase is ZB004 in?

ZB004 is in Phase 1 clinical development. A Phase 1 study of ZB004 in healthy participants has been completed. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is ZB004 in?

ZB004 has one completed clinical trial, NCT05794516, titled "A Safety and Pharmacokinetics Study of ZB004 in Healthy Participants." This Phase 1 study enrolled 40 healthy volunteers in New Zealand and was placebo-controlled, randomized, and double-blind.

Is ZB004 the same as other drugs?

ZB004 is a distinct investigational small molecule developed by Zenas BioPharma, Inc. No alternative names for ZB004 have been reported in its clinical trial record.