Status:
COMPLETED
Pharmacokinetics/Pharmacodynamics of NOX-H94 in the Human Endotoxemia Model
Lead Sponsor:
TME Pharma AG
Conditions:
Anemia of Chronic Disease
Eligibility:
MALE
18-35 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the effect of the anti-hepcidin Spiegelmer NOX-H94 on iron homeostasis during systemic inflammation induced by endotoxin. In the human endotoxemia model, intrav...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01522794
Start Date
January 1 2012
End Date
April 1 2012
Last Update
November 10 2014
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB