NCT03046459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2016

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

January 25, 2017

Last Update Submit

June 21, 2017

Conditions

Healthy

Keywords

cytokinesinterleukin-2Safety Issues

Outcome Measures

Primary Outcomes (1)

  • The proportion of subjects with related, treatment-emergent adverse events

    30 days

Secondary Outcomes (3)

  • 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

  • PD: Effects of BNZ132-1-40 on the expression of T cells as determined by FACS analysis

    30 days

Study Arms (1)

BNZ132-1-40

EXPERIMENTAL

a range of IV doses

Biological: BNZ132-1-40

Interventions

BNZ132-1-40BIOLOGICAL

pegylated peptide inhibiting IL-2, IL-9 and IL-15

BNZ132-1-40

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Phoenix, Arizona, 85283, United States

Location

Related Publications (1)

  • 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.

    PMID: 26183780BACKGROUND

Study Officials

  • Paul A Frohna, MD, PhD

    Bioniz Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

February 8, 2017

Study Start

November 1, 2016

Primary Completion

June 5, 2017

Study Completion

June 5, 2017

Last Updated

June 22, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)