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

NCT03239379 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-05-15

No results posted yet for this study

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

Interventions

DRUG

BNZ132-1-40

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

DRUG

Placebo

Normal Saline

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Bioniz Therapeutics

    lead INDUSTRY

Principal Investigators

  • Paul A Frohna, MD, PhD · Bioniz Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-30
Primary Completion
2018-02-15
Completion
2018-03-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03239379 on ClinicalTrials.gov