Dose Escalation, Randomized, Placebo Controlled Study to Investigate the Effects of Intravenous Heme Arginate on Heme Oxygenase-1 (HO-1) and Heme Metabolism in Association With HO-1 Gene GTn Promoter Polymorphism in Healthy Male Subjects (HEMAHS)

NCT00682370 Phase 1 COMPLETED

Heme oxygenase 1 (HO-1) serves as a protective gene. It has been shown that one factor modulating HO-1 activity is a genetic variation in the HO-1 gene (functional GT length polymorphism in the promotor region). Heme arginate is a strong inducer of HO-1 as shown in several animal experimental studies. The aim of this clinical trial is to evaluate the HO-1 stimulation of heme arginate in healthy humans.

Details

Lead sponsor	Daniel Doberer
Phase	Phase 1
Status	COMPLETED
Enrolment	15
Start date	2007-10
Completion	2008-07

Conditions

• Healthy Subjects
• Heme Oxygenase
• Genetic Polymorphism

Interventions

• saline solution
• heme arginate
• heme arginate
• heme arginate

Primary outcomes

• The maximal HO-1 mRNA expression in PBMCs — 2 months

Countries

Austria