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

Main Inclusion Criteria:

• BMI between 18 and 30 kg/m², with a lower limit of body weight of 50 kg
• Healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters
• Serum iron and red blood parameters Hb, MCV, ferritin, serum iron, and total iron binding capacity within reference range

Main Exclusion Criteria:

• Use of any medication, recreational drugs or anti-oxidant vitamin supplements within 7 days
• Use of caffeine, nicotine, or alcohol within 1 day
• Previous participation in a trial where LPS was administered
• Surgery or trauma with significant blood loss or blood donation within 3 months
• History, signs or symptoms of cardiovascular disease (vaso-vagal collapse or of orthostatic hypotension, Resting pulse rate ≤45 or ≥100/min, Hypertension, Hypotension, ECG conduction abnormalities)
• Renal impairment: plasma creatinine >120 µmol/L
• Liver function tests (alkaline phosphatase, AST, ALT and γ-GT) outside of the reference range or total bilirubin >20 µmol/L
• Hemoglobin or iron parameters (iron, transferring saturation, ferritin) outside of the reference ranges
• History of asthma
• Immuno-deficiency
• Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies and HCV antibodies unless antibody titer is induced by vaccination
• CRP > reference range or clinically significant acute illness, including infections, within 2 weeks
• Treatment with investigational drugs or participation in any other clinical trial within 30 days prior to study drug administration
• Known or suspected of not being able to comply with the trial protocol
• Inability to personally provide written informed consent and/or take part in the study