NCT03239379

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

Completed Phase 1 Last updated 15 May 2018

What this trial tests

Phase 1 trial testing BNZ132-1-40 in Safety and Tolerability in Healthy Subjects in 32 participants. Completed in 8 March 2018.

Timeline

30 October 2017

Primary endpoint
15 February 2018

8 March 2018

Quick facts

Lead sponsor	Bioniz Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	32
Start date	30 October 2017
Primary completion	15 February 2018
Estimated completion	8 March 2018
Sites	1 location across United States

Drugs / interventions tested

• BNZ132-1-40 — full drug profile →
• Placebo

Conditions studied

• Safety and Tolerability in Healthy Subjects — all drugs for Safety and Tolerability in Healthy Subjects →

Sponsor

Bioniz Therapeutics — full company profile →

Who can join

Adults 18 to 55, any sex, with Safety and Tolerability in Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. IL-2 and IL-15 blockade by BNZ-1, an inhibitor of selective γ-chain cytokines, decreases leukemic T-cell viability.
   Wang TT, Yang J, Zhang Y, Zhang M, et al · · 2019 · cited 36× · PMID 30353031 · DOI 10.1038/s41375-018-0290-y