NCT01522794

Pharmacokinetics/Pharmacodynamics of NOX-H94 in the Human Endotoxemia Model

Randomized Double Blind Placebo Controlled PK/PD Study on the Effects of a Single Intravenous Dose of NOX-H94 on Serum Iron During Experimental Human Endotoxemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: TME Pharma AG · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effect of the anti-hepcidin Spiegelmer NOX-H94 on iron homeostasis during systemic inflammation induced by endotoxin. In the human endotoxemia model, intravenously administered lipopolysaccharide elicits an inflammatory response with release of pro-inflammatory cytokines, such as IL-6 and TNF-alfa, with subsequent induction of hepcidin. As a consequence of hepcidin induction, serum iron concentrations decrease. This study in healthy subjects investigates the capacity of NOX-H94 to inactivate hepcidin and to prevent serum iron decrease in a pathophysiological model prior to studying the efficacy of NOX-H94 in patients with anemia of chronic disease.

Conditions

• Anemia of Chronic Disease

Interventions

Type	Name	Description
DRUG	NOX-H94	single i.v. infusion
DRUG	Placebo solution	single i.v. infusion

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-03-01
• Completion: 2012-04-01
• First posted: 2012-02-01
• Last updated: 2014-11-10

Locations

1 site across 1 country: Netherlands