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BNZ132-1-40

Phase 1

Safety and Tolerability in Healthy Subjects | Small molecule | Other |Equillium, Inc.|Last Updated: May 25, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

BNZ132-1-40 · 3 trials · 4 indications

Phase 1 3
NCT03239392A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCLLGL Leukemia
COMPLETED50 Analytics
NCT03239379A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult SubjectsSafety and Tolerability in Healthy Subjects
COMPLETED32 Analytics
NCT03046459A First-in-Human Study of BNZ132-1-40Healthy
COMPLETED18 Analytics
PHASE1COMPLETED
A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL
LGL LeukemiaUnlock trial analytics
PHASE1COMPLETED
A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult Subjects
Safety and Tolerability in Healthy SubjectsUnlock trial analytics
PHASE1COMPLETED
A First-in-Human Study of BNZ132-1-40
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence, severity and relationship of treatment-emergent adverse events
1 month
The proportion of subjects with related, treatment-emergent adverse events
30 days

Secondary Endpoints

Pharmacodynamics
16 weeks
Single-dose and steady-state Cmax
16 weeks
Single-dose and steady-state AUC
16 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BNZ-1EXPERIMENTALIV PEGylated BNZ132-1-40
PlaceboPLACEBO_COMPARATORNormal saline
BNZ132-1-40EXPERIMENTALPEGylated BNZ-1 for Injection

Interventions

NameTypeDescription
BNZ132-1-40DRUGInjectable PEGylated peptide antagonist that binds to the common gamma chain (γc) signaling receptor for the cytokines interleukin (IL)-2, IL-9, and IL-15
PlaceboDRUGNormal Saline
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Willing and able to consent and participate in the study. * Agrees not to receive any other investigational product or therapy while participating in this study. * Must be: * Currently using two forms of effective birth control (one of which is a barrier method) for the dur...

Countries:United States
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Frequently asked questions about BNZ132-1-40

What is BNZ132-1-40 used for?

BNZ132-1-40 is an investigational monoclonal antibody being studied for use in LGL leukemia and refractory CTCL, as well as for safety and tolerability in healthy subjects. It is currently in Phase 1 clinical development and is not yet approved by the FDA.

What does BNZ132-1-40 target?

BNZ132-1-40 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being investigated for its potential effects in LGL leukemia and refractory CTCL, though the exact mechanism of action is not publicly detailed.

Who makes BNZ132-1-40?

BNZ132-1-40 is being developed by Equillium, Inc., a biopharmaceutical company. Equillium is publicly traded under the ticker symbol EQ on the NASDAQ stock exchange.

What phase is BNZ132-1-40 in?

BNZ132-1-40 is in Phase 1 clinical development. All three clinical trials for BNZ132-1-40 are Phase 1 studies and have been completed. The drug is investigational and has not received FDA approval.

What clinical trials is BNZ132-1-40 in?

BNZ132-1-40 has been studied in three completed Phase 1 trials: NCT03046459, a first-in-human study in healthy subjects; NCT03239379, a multiple-dose study in healthy adults; and NCT03239392, a dose-ranging study in patients with LGL leukemia or refractory CTCL.

Is BNZ132-1-40 the same as BNZ-1?

BNZ132-1-40 is also referred to as BNZ-1 in clinical trial records. The trial NCT03239392, titled 'A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL,' uses the name BNZ-1 to refer to the same investigational drug.