MedDRA - 10002073: Anaemia of chronic disease D63.8
Conditions
Interventions
Group 1: Single IV infusion of 1.2 mg/kg NOX-H94
Group 2: Single IV injection of Placebo
Sponsors
NOXXON Pharma AG
Eligibility
Sex/Gender
Male
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria: - Use of any medication, recreational drugs or anti-oxidant vitamin supplements within 7 days - Use of caffeine, nicotine, or alcohol or 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 ?-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum iron: Change versus baseline; comparison of subjects treated with NOX-H94 versus placebo at 9h post LPS | — |
Secondary
| Measure | Time frame |
|---|---|
| Iron homeostasis (absolute and change vs. baseline): serum iron, transferrin saturation, ferritin, reticulocyte hemoglobin content, hemoglobin (Hb), mean cell volume, mean cell hemoglobin; Pharmacokinetic profile of NOX-H94; Safety and tolerability; Effects of NOX-H94 on innate immune response. Observation period: 2 weeks (Day 1, 2, 8, 15). | — |
Countries
Netherlands
Contacts
Public ContactKai Riecke
NOXXON Pharma AG
Outcome results
None listed