Anemia of Chronic disease inflammation associated anemia
Conditions
Interventions
The volunteers will be randomized to 2 intervention groups.
Group 1. NOX-H94 (N=12):
T= 0: 2ng/kg LPS i.v.
T=0.5 hrs: NOX-H94 1.2 mg/kg i.v.
Group 2. Placebo (N=12):
T= 0: 2ng/kg LPS i.v.
T= 0.5 h
Sponsors
NOXXON Pharma AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent to participate in this trial 2. Male subjects aged 18 to 35 years inclusive 3. Subjects and their female partners have to agree to use a reliable way of contraception from screening until 2 months after study drug administration. 4. BMI between 18 and 30 kg/m², with a lower limit of body weight of 50 kg 5. Healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters 6. Serum iron and red blood parameters Hb, MCV, ferritin, serum iron, and total iron binding capacity within reference range
Exclusion criteria
Exclusion criteria: 1. Use of any medication, recreational drugs or anti-oxidant vitamin supplements within 7 days prior to profiling day 2. Use of caffeine, nicotine, or alcohol or within 1 day prior to profiling day 3. Previous participation in a trial where LPS was administered 4. Surgery or trauma with significant blood loss or blood donation within 3 months prior to profiling day 5. History, signs or symptoms of cardiovascular disease, in particular • History of frequent vaso-vagal collapse or of orthostatic hypotension • Resting pulse rate =100 beats / min • Hypertension (RR systolic >160 or RR diastolic >90) • Hypotension (RR systolic 120 µmol/L 7. Liver function tests (alkaline phosphatase, AST, ALT and γ-GT) outside of the reference range or total bilirubin >20 µmol/L 8. Hemoglobin or iron parameters (iron, transferrin saturation, ferritin) outside of the reference ranges 9. History of asthma 10. Immuno-deficiency 11. Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies and HCV antibodies unless antibody titer is induced by vaccination 12. CRP > reference range or clinically significant acute illness, including infections, within 2 weeks before profiling day of study drug. 13. Treatment with investigational drugs or participation in any other clinical trial within 30 days prior to study drug administration 14. Known or suspected of not being able to comply with the trial protocol. 15. Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint • Change in serum iron concentration at 9 hours after LPS administration versus baseline; comparison of subjects treated with NOX H94 versus placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints • Change in serum iron concentrations at 6 and 12 hours after LPS administration versus baseline • Concentrations of serum iron and of markers of iron homeostasis up to 48 h after LPS injection: serum iron, transferrin saturation (TSAT), ferritin, reticulocyte hemoglobin content (CHR), hemoglobin (Hb), mean cell volume (MCV), mean cell hemoglobin (MCH): AUC of serum iron concentrations, ANOVA of repeat measures of all data points • Concentration of hepcidin up to 1 week after LPS injection • Concentrations of pro-inflammatory and anti-inflammatory cytokines up to 48 h after LPS injection: TNF a, IL 6, IL 1RA, IL 10 to document the inflammatory reaction • Pharmacokinetic profile of NOX H94 • Safety and tolerability | — |
Countries
Netherlands
Outcome results
None listed