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:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT01685359
Eligibility Criteria:
Inclusion Criteria:
* Agree to all the purposes of the study by signing and dating the Informed Consent;
* Male, aged between 20 and 55 years, clinically healthy;
* BMI between 18.5 and 30;
* Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
* VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells.
* Human serum ferritin between 36-262 mcg / L;
* Counting of reticulocytes in peripheral blood ≤ 3%;
* Serum erythropoietin \< 30 mIU / mL.
Exclusion Criteria:
* Participation in clinical trials in the 12 months preceding the survey;
* Body weight \> 100 kg;
* Presence of iron deficiency anemia;
* Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
* Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
* Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
* Hormone therapy in the period of 02 months preceding the beginning of the practical phase (administration of the drug) of the study;
* Administration of any drug in the 02 weeks prior to the start of the practical period of the study;
* Clinical history of autoimmune or hereditary anemia;
* Clinical history of chronic bleeding;
* Clinical history of acute bleeding in the 30 days preceding the beginning of practical phase of the study (administration of the drug);
* Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation;
* Current or previous history (less than 12 months) of illicit drug abuse and / or tobacco and / or alcohol or having consumed alcohol within 48 hours prior to the practical study periods (administration of the drug);
* Prior therapies with erythropoietin;
* Albumin below 3.5 g/dL or higher than 4.8 g/dL;
* Signs or clinical history of bone marrow aplasia;
* History and clinical or laboratory liver disease;
* History and clinical or laboratory nephropathy;
* Principal Investigator of the study criteria.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT01685359
Study Brief:
Protocol Section:
NCT01685359