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Completed

NCT Number: NCT03046459

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

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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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Phoenix, Arizona, 85283, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Recent systemic infections
  • Clinically-significant abnormal clinical labs, ECG or physical examination
  • Immunization 30 days prior to study

Treatment and study plan

BNZ132-1-40

Biological

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

Primary outcomes

  1. The proportion of subjects with related, treatment-emergent adverse events

    Time frame: 30 days

Secondary outcomes

  1. PK: Exposure as determined by maximum plasma concentration (Cmax)

    Time frame: 1 Day

  2. PK: Exposure as determined by area under the concentration-time curve (AUC)

    Time frame: 30 days

  3. PD: Effects of BNZ132-1-40 on the expression of T cells as determined by FACS analysis

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Bioniz Therapeutics

Industry

Collaborators

  • Celerion

Registry information

Official study title

A First-in-human Study to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of BNZ132-1-40

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 8, 2017
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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