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

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-06-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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BNZ132-1-40

a range of IV doses

Group Type EXPERIMENTAL

BNZ132-1-40

Intervention Type BIOLOGICAL

pegylated peptide inhibiting IL-2, IL-9 and IL-15

Interventions

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BNZ132-1-40

pegylated peptide inhibiting IL-2, IL-9 and IL-15

Intervention Type BIOLOGICAL

Eligibility Criteria

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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