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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2018-03-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Safety and Tolerability in Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Single-blind, placebo-controlled

Study Groups

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Placebo

Normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal Saline

BNZ132-1-40

PEGylated BNZ-1 for Injection

Group Type EXPERIMENTAL

BNZ132-1-40

Intervention Type DRUG

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

Interventions

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BNZ132-1-40

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

Intervention Type DRUG

Placebo

Normal Saline

Intervention Type DRUG

Other Intervention Names

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BNZ-1

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes