Trial | NCT03046459  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    18
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.
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.
Study Started
Nov 30
2016
Primary Completion
Jun 05
2017
Study Completion
Jun 05
2017
Last Update
Jun 22
2017

Biological BNZ132-1-40

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

BNZ132-1-40 Experimental

a range of IV doses

Criteria 

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
No Results Posted