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BNZ132-1-40

Phase 1

Healthy | Monoclonal antibody | Other |Equillium, Inc.|Last Updated: May 25, 2021

Development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Feb 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment18

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 healthy subjects and in patients with LGL leukemia or refractory cutaneous T-cell lymphoma (CTCL). It has been evaluated in early-phase clinical trials to assess safety, tolerability, and dosing.

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 listed for the drug are Phase 1 studies that have been completed. It remains an investigational agent and has not been approved by regulatory authorities.

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?

Yes, BNZ132-1-40 is also referred to as BNZ-1 in clinical trial records. The trial NCT03239392, which studied the drug in LGL leukemia and refractory CTCL, uses the name BNZ-1 in its title.