In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

Excessive inflammation is associated with tissue damage caused by over-activation of the innate immune system. This can range from mild disease to extreme conditions such as multiple organ failure (MOF). In marked contrast to adaptive immunity which is very sensitive to immune modulators such as steroids, the innate immune system cannot be sufficiently targeted by currently available anti-inflammatory drugs.

We hypothesize that C1-esterase inhibitor can modulate the innate immune response.

In this study, human endotoxemia will be used as a model for inflammation. Subjects will, additionally to endotoxin, receive C1 esterase inhibitor or placebo. Blood will be sampled to determine the levels of markers of the innate immune response.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Radboud University
• Treatments: Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein; Complement C1s

Criteria

Inclusion Criteria:

• Healthy male volunteers (18-35 years old)

Exclusion Criteria:

• Relevant medical history

• Drug-, nicotine-, alcohol abuses

• Tendency towards fainting

• Hyper- or hypotension