NCT05653713

Effects of CSL324 in the Lung After Segmental Challenge

A Phase 1b, Randomized, Double-blind, Placebo-controlled Study in Healthy Volunteers to Investigate the Effects of CSL324 in the Lung After Segmental Challenge With Endotoxin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1b, randomized, double-blind, placebo-controlled study in healthy volunteers to investigate the antiinflammatory effect of pretreatment with CSL324 on response to a lipopolysaccharide (LPS) endotoxin challenge in a single lung segment. Saline will be instilled into a segment in the contralateral lung for the purpose of comparison.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CSL324	Single intravenous (IV) dose of CSL324
DRUG	Placebo	IV dose of 0.9% saline

Timeline

• Start date: 2022-12-20
• Primary completion: 2023-07-21
• Completion: 2023-07-21
• First posted: 2022-12-16
• Last updated: 2023-11-29

Locations

1 site across 1 country: Germany