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ZB004

Phase 1

Undisclosed | Small molecule | Other |Zenas BioPharma, Inc.|Trials Updated: Apr 13, 2025

ZB004 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2023

ZB004 target and mechanism

Molecular targetIGF1R
Target classReceptor
ModalitySmall molecule

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

ZB004 clinical trials

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
Healthy VolunteersUnlock trial analytics

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 has been studied in a Phase 1 clinical trial in healthy volunteers. ZB004 is designed to target IGF1R, a receptor. Its therapeutic indications have not been disclosed, and it remains in clinical development.

What does ZB004 target?

ZB004 targets IGF1R, the insulin-like growth factor 1 receptor. IGF1R is a cell surface receptor, and ZB004 is a small molecule directed at it. Targeting this receptor is the mechanism described for the investigational compound as it continues through early clinical development.

Who makes ZB004?

ZB004 is being developed by Zenas BioPharma, Inc., which trades under the ticker ZBIO. The company is the sponsor of the clinical program evaluating ZB004. The asset is an investigational small molecule and has not been approved for any indication.

What phase is ZB004 in?

ZB004 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The study was a randomized, double-blind, placebo-controlled trial of 40 healthy participants conducted in New Zealand.

What clinical trials is ZB004 in?

ZB004 has been evaluated in one completed Phase 1 trial, NCT05794516, titled A Safety and Pharmacokinetics Study of ZB004 in Healthy Participants. The trial enrolled 40 healthy volunteers in New Zealand, was randomized, double-blind, and placebo-controlled, and included participants aged 18 years and older.