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ZB001

Phase 1

Healthy Volunteers | Small molecule | Other |Zenas BioPharma, Inc.|Last Updated: Apr 6, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05542303A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy SubjectsPHASE1 COMPLETED 24Oct 16, 2022Apr 4, 2023Apr 6, 20251 China
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Study Endpoints
Primary Endpoints
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
during the study, up to 4 weeks
Secondary Endpoints
ZB001 concentrations in the blood over time
Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks
Serum ZB001 antidrug antibody (ADA) titers
Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ZB001 for injectionEXPERIMENTALTreated different dose cohorts with single intravenous injection of ZB001
Interventions
NameTypeDescription
ZB001 for injectionDRUGDose Cohort1 (3mg/kg) ZB001 of single IV injection
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy Chinese subjects between 18 and 55 years old (inclusive) at Screening 2. Free of any clinically significant disease or medical condition at screening as determinedby the Investigator 3. Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 32 kg/m2 4. Women m...

Countries:China
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