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A Multiple-Dose Study of Intravenous BNZ132‑1-40 in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT03239379
Recruitment Status : Completed
First Posted : August 4, 2017
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
Celerion
Information provided by (Responsible Party):
Bioniz Therapeutics

Brief Summary:
This study is a single-center, randomized, single‑blind, placebo (PBO)-controlled, multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1 administered to healthy adult subjects once weekly (QW) for 4 doses or once every other week (QOW) for 3 doses. Five cohorts of 6 subjects randomized 5 BNZ-1:1 PBO are planned to be enrolled in the trial. Participants will be followed for 4 weeks after the last dose for safety monitoring, and collection of PK and PD samples.

Condition or disease Intervention/treatment Phase
Safety and Tolerability in Healthy Subjects Drug: BNZ132-1-40 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Single-blind, placebo-controlled
Primary Purpose: Treatment
Official Title: A Multiple-Dose Study of Intravenous BNZ132‑1-40 in Healthy Adult Subjects
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : March 8, 2018

Arm Intervention/treatment
Placebo Comparator: Placebo
Normal saline
Drug: Placebo
Normal Saline

Experimental: BNZ132-1-40
PEGylated BNZ-1 for Injection
Drug: BNZ132-1-40
Injectable peptide antagonist of IL-2, IL-9 and IL-15
Other Name: BNZ-1




Primary Outcome Measures :
  1. Incidence, severity and relationship of treatment-emergent adverse events [ Time Frame: 8 weeks ]
    general safety evaluation by principal investigator


Secondary Outcome Measures :
  1. single-dose and steady state Cmax [ Time Frame: 8 weeks ]
    plasma concentrations collected at multiple times after the first and last doses

  2. single-dose and steady state AUC0-t [ Time Frame: 8 weeks ]
    plasma concentrations collected at multiple times after the first and last doses

  3. Steady-state Elimination half-life (t1/2) [ Time Frame: 8 weeks ]
    plasma concentrations collected at multiple times after the last dose

  4. Change from baseline for Regulatory T-cells (Tregs) [ Time Frame: 8 weeks ]
    Flow cytometry of PBMCs at multiple time points post dose

  5. Change from baseline for Natural Killer Cells [ Time Frame: 8 weeks ]
    Flow cytometry of PBMCs at multiple time points post dose

  6. Change from baseline for CD8+ central memory T-cells (Tcm) [ Time Frame: 8 weeks ]
    Flow cytometry of PBMCs at multiple time points post dose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Non-smoker.
  2. Weight ≤100 kg (due to drug supply limitations).
  3. Body Mass Index (BMI) ≥19 and <35 kg/m2.
  4. Healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital signs (pulse rate, blood pressure, respiratory rate), and ECG.
  5. Willing and able to consent and participate in the study.
  6. Subject agrees not to receive any other investigational product or therapy while participating in this study.
  7. Agrees to use adequate effective birth control methods prior to, during and for 30 days after the study.

Exclusion Criteria:

  1. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator.
  2. History of cancer (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
  3. History of or currently active primary or secondary immunodeficiency.
  4. Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal infection of nail beds, minor upper respiratory tract infection, and minor skin conditions]), or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of screening or oral antibiotics within 14 days prior to screening.
  5. Subject has received other investigational products or therapy in the past 30 days prior to study drug administration.
  6. Serologic evidence of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
  7. Subject has received an immunization within 14 days prior to study drug administration.
  8. History of alcohol or drug abuse within 1 year prior to screening.
  9. Subject requires the ongoing use of prescription medication other than oral contraceptives.

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): NCT03239379


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

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Responsible Party: Bioniz Therapeutics
ClinicalTrials.gov Identifier: NCT03239379     History of Changes
Other Study ID Numbers: BNZ1-CT-102
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bioniz Therapeutics:
cytokine inhibitor
IL-2
IL-9
IL-15