NCT03239379

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Bioniz Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	BNZ132-1-40	Injectable peptide antagonist of IL-2, IL-9 and IL-15
DRUG	Placebo	Normal Saline

Timeline

• Start date: 2017-10-30
• Primary completion: 2018-02-15
• Completion: 2018-03-08
• First posted: 2017-08-04
• Last updated: 2018-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study