NCT03046459

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Bioniz Therapeutics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	BNZ132-1-40	pegylated peptide inhibiting IL-2, IL-9 and IL-15

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-06-05
• Completion: 2017-06-05
• First posted: 2017-02-08
• Last updated: 2017-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study