A First-in-Human Study of BNZ132-1-40 | NCT03046459

Studies
A First-in-Human Study of BNZ132-1-40

NCT03046459

Sponsor

Bioniz Therapeutics

Status

Completed

Last Update Posted

Jun 22, 2017Actual

Enrollment

18Actual

Phase

Phase 1

Conditions

Healthy

Interventions

BNZ132-1-40

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Jun 5, 2017Actual

Completion Date

Jun 5, 2017Actual

First Submitted Date

Jan 25, 2017

First Submission Date that Met QC Criteria

Feb 6, 2017

First Posted Date

Feb 8, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2017

Last Update Posted Date

Jun 22, 2017Actual

Name	Class
Celerion	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an open-label, single ascending dose study to characterize the safety and PK/PD profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2 family.

Detailed Description

This is a open-label study of single doses of intravenous BNZ132-1-40 administered to healthy adult subjects. Subjects are followed for 30 days after treatment for collection of safety, PK and PD data. Cohorts of up to 6 subjects will be enrolled for each dose level.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BNZ132-1-40	Experimental	a range of IV doses	Biological: BNZ132-1-40

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BNZ132-1-40	Biological	pegylated peptide inhibiting IL-2, IL-9 and IL-15	BNZ132-1-40

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of subjects with related, treatment-emergent adverse events		30 days

Secondary Outcomes

Measure	Description	Time Frame
PK: Exposure as determined by maximum plasma concentration (Cmax)		1 Day
PK: Exposure as determined by area under the concentration-time curve (AUC)		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

males and non-pregnant, non-lactating females
no ongoing clinically significant medical condition
willing and able to provide informed consent
no use of Rx or OTC medications, other than oral contraceptives

Exclusion Criteria:

Recent systemic infections
Clinically-significant abnormal clinical labs, ECG or physical examination
Immunization 30 days prior to study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul A Frohna, MD, PhD	Bioniz Therapeutics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Celerion		Phoenix	Arizona	85283	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26183780	Background	Nata T, Basheer A, Cocchi F, van Besien R, Massoud R, Jacobson S, Azimi N, Tagaya Y. Targeting the binding interface on a shared receptor subunit of a cytokine family enables the inhibition of multiple member cytokines with selectable target spectrum. J Biol Chem. 2015 Sep 11;290(37):22338-51. doi: 10.1074/jbc.M115.661074. Epub 2015 Jul 16.