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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03046459
First Posted: February 8, 2017
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Celerion
Information provided by (Responsible Party):
Bioniz Therapeutics
  Purpose
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.

Condition Intervention Phase
Healthy Biological: BNZ132-1-40 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A First-in-human Study to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of BNZ132-1-40

Further study details as provided by Bioniz Therapeutics:

Primary Outcome Measures:
  • The proportion of subjects with related, treatment-emergent adverse events [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Actual Study Start Date: November 2016
Study Completion Date: June 5, 2017
Primary Completion Date: June 5, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BNZ132-1-40
a range of IV doses
Biological: BNZ132-1-40
pegylated peptide inhibiting IL-2, IL-9 and IL-15

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046459


Locations
United States, Arizona
Celerion
Phoenix, Arizona, United States, 85283
Sponsors and Collaborators
Bioniz Therapeutics
Celerion
Investigators
Study Director: Paul A Frohna, MD, PhD Bioniz Therapeutics, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Bioniz Therapeutics
ClinicalTrials.gov Identifier: NCT03046459     History of Changes
Other Study ID Numbers: BNZ-CT-101
First Submitted: January 25, 2017
First Posted: February 8, 2017
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bioniz Therapeutics:
cytokines
interleukin-2
Safety Issues