inflammation sepsis
Conditions
Interventions
Subjects will be tested in a cross-over design in 2 separate sequential
sessions, 1.5-4 weeks apart. A total of 10 subjects will be randomly assigned
to one of two dosing groups in a 1:1ratio: C1 IN
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy young male adults (18-35 years)
Exclusion criteria
Exclusion criteria: Use of any medication Congenital or acquired C1 inhibitor deficiency Immune deficiency History of allergic reaction to blood products Chronic inflammatory diseases Smoking History, signs or symptoms of cardiovascular disease (Family) history of cerebrovascular disease Previous vagal collaps Hypertension (defined as RR systolic > 160 or RR diastolic > 90) Hypotension (defined as RR systolic 120 µmol/l) Liver enzyme abnormalities or positive hepatitis serology Positive HIV test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study endpoint is the concentration of circulating cytokines and C reactive protein after LPS in the absence and presence of C1 INH substitution. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic and pharmacodynamic data will be collected with respect to the anti-inflammatory effects of C1 INH. Effects on the PMN phenotype and function will be determined. C1 INH concentration and activity as well as anaphylatoxin concentrations will be measured and compared to baseline values. | — |
Countries
Netherlands
Outcome results
None listed