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ZB004

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05794516A Safety and Pharmacokinetics Study of ZB004 in Healthy ParticipantsPHASE1 COMPLETED 40Jun 19, 2023Mar 21, 2024Apr 13, 20251 New Zealand
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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 — 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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