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

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.

Study Overview

• Status: Completed
• Conditions: Safety and Tolerability in Healthy Subjects
• Intervention / Treatment: Drug: Placebo; Drug: BNZ132-1-40

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: BNZ-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, severity and relationship of treatment-emergent adverse events	general safety evaluation by principal investigator	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
single-dose and steady state Cmax	plasma concentrations collected at multiple times after the first and last doses	8 weeks
single-dose and steady state AUC0-t	plasma concentrations collected at multiple times after the first and last doses	8 weeks
Steady-state Elimination half-life (t1/2)	plasma concentrations collected at multiple times after the last dose	8 weeks
Change from baseline for Regulatory T-cells (Tregs)	Flow cytometry of PBMCs at multiple time points post dose	8 weeks
Change from baseline for Natural Killer Cells	Flow cytometry of PBMCs at multiple time points post dose	8 weeks
Change from baseline for CD8+ central memory T-cells (Tcm)	Flow cytometry of PBMCs at multiple time points post dose	8 weeks

Collaborators and Investigators

• Sponsor: Bioniz Therapeutics
• Collaborators: Celerion
• Investigators: Study Director: Paul A Frohna, MD, PhD, Bioniz Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): March 8, 2018

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 12, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: IL-2; cytokine inhibitor; IL-9; IL-15
• Other Study ID Numbers: BNZ1-CT-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No