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BNZ132-1-40

Phase 1

Safety and Tolerability in Healthy Subjects | Small molecule | Other |Equillium, Inc.|Last Updated: May 15, 2018

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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03239379A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult SubjectsPHASE1 COMPLETED 32Oct 30, 2017Mar 8, 2018May 15, 20181 United States
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Study Endpoints
Primary Endpoints
Incidence, severity and relationship of treatment-emergent adverse events
8 weeks

general safety evaluation by principal investigator

Secondary Endpoints
single-dose and steady state Cmax
8 weeks
single-dose and steady state AUC0-t
8 weeks
Steady-state Elimination half-life (t1/2)
8 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORNormal saline
BNZ132-1-40EXPERIMENTALPEGylated BNZ-1 for Injection
Interventions
NameTypeDescription
BNZ132-1-40DRUGInjectable peptide antagonist of IL-2, IL-9 and IL-15
PlaceboDRUGNormal Saline
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Non-smoker. 2. Weight ≤100 kg (due to drug supply limitations). 3. Body Mass Index (BMI) ≥19 and \<35 kg/m2. 4. Healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital signs (pulse rate, blood pressure, res...

Countries:United States
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