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

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ClinicalTrials.gov Identifier: NCT03046459
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
Celerion
Information provided by (Responsible Party):
Bioniz Therapeutics

Tracking Information
First Submitted Date  ICMJE January 25, 2017
First Posted Date  ICMJE February 8, 2017
Last Update Posted Date June 22, 2017
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2017)
The proportion of subjects with related, treatment-emergent adverse events [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03046459 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2017)
  • PK: Exposure as determined by maximum plasma concentration (Cmax) [ Time Frame: 1 Day ]
  • PK: Exposure as determined by area under the concentration-time curve (AUC) [ Time Frame: 30 days ]
  • PD: Effects of BNZ132-1-40 on the expression of T cells as determined by FACS analysis [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A First-in-Human Study of BNZ132-1-40
Official Title  ICMJE A First-in-human Study to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of BNZ132-1-40
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE Biological: BNZ132-1-40
pegylated peptide inhibiting IL-2, IL-9 and IL-15
Study Arms  ICMJE Experimental: BNZ132-1-40
a range of IV doses
Intervention: Biological: BNZ132-1-40
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2017)
18
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2017)
20
Actual Study Completion Date  ICMJE June 5, 2017
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03046459
Other Study ID Numbers  ICMJE BNZ-CT-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bioniz Therapeutics
Study Sponsor  ICMJE Bioniz Therapeutics
Collaborators  ICMJE Celerion
Investigators  ICMJE
Study Director: Paul A Frohna, MD, PhD Bioniz Therapeutics, Inc.
PRS Account Bioniz Therapeutics
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP