Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT01522794
Eligibility 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
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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01522794
Study Brief:
Protocol Section:
NCT01522794