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

NCT03239379 | Completed Phase 1 FDA Drug

• 1 other identifier: BNZ1-CT-102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety and Tolerability in Healthy Subjects

Keywords

cytokine inhibitor; IL-2; IL-9; IL-15

Outcome Measures

Primary Outcomes (1)

• Incidence, severity and relationship of treatment-emergent adverse events

  general safety evaluation by principal investigator

  8 weeks

Secondary Outcomes (6)

• single-dose and steady state Cmax

  8 weeks

• single-dose and steady state AUC0-t

  8 weeks

• Steady-state Elimination half-life (t1/2)

  8 weeks

• Change from baseline for Regulatory T-cells (Tregs)

  8 weeks

• Change from baseline for Natural Killer Cells

  8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal saline

Drug: Placebo

BNZ132-1-40

EXPERIMENTAL

PEGylated BNZ-1 for Injection

Drug: BNZ132-1-40

Interventions

BNZ132-1-40 DRUG

Injectable peptide antagonist of IL-2, IL-9 and IL-15

Also known as: BNZ-1

BNZ132-1-40

Placebo DRUG

Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• History of cancer (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
• History of or currently active primary or secondary immunodeficiency.
• 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.
• Subject has received other investigational products or therapy in the past 30 days prior to study drug administration.
• Serologic evidence of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
• Subject has received an immunization within 14 days prior to study drug administration.
• History of alcohol or drug abuse within 1 year prior to screening.
• Subject requires the ongoing use of prescription medication other than oral contraceptives.

Sponsors & Collaborators

• Bioniz Therapeutics: lead
• Celerion: collaborator

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Study Officials

• Paul A Frohna, MD, PhD

  Bioniz Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Single-blind, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 4, 2017
• Study Start: October 30, 2017
• Primary Completion: February 15, 2018
• Study Completion: March 8, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)