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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT05594433
Eligibility Criteria:
Inclusion Criteria:
* Healthy male volunteers,
* Age ≥ 18 years and ≤ 60 years,
* Agreeing to the collection of blood products by whole blood donation for scientific research purposes,
* Fit for collection by the collecting physician after a medical examination including measurement of blood pressure, heart rate, electrocardiogram and assessment of venous potential,
* Minimum weight: 50 kg,
* Body mass index (BMI) \< 30,
* Haemoglobin level between 13 g/dL and 18 g/dL,
* Platelet count between 150.106/mL and 400.106/mL
* White blood cell count ≥ 3.9.106/mL with neutrophils ≥ 2.5.106/mL,
* Agreement to be registered in the national research file,
Exclusion Criteria:
* Any cardiopulmonary abnormality on initial clinical and ECG assessment
* Clinical measurement of systolic BP ≤ 110 mmHg and/or diastolic BP \< 70 mmHg on initial workup
* Any blood work-up abnormality deemed significant by the investigator at the time of the initial work-up,
* Previous administration of any haematopoietic growth factor,
* Regular use of medication(s) within 8 days prior to the start of the Granocyte mobilisation phase,
* Any significant cardiovascular history within the last 2 years
* Any history of severe pulmonary disease (including bacterial or viral pneumonia)
* Any history of cancer (solid tumours or haematological malignancies)
* Anysevere neurological history
* Any severe psychiatric history
* Renal history (creatinine clearance from stage 1 to stage 5 of the HAS 2012 classification)
* Twins with a living twin brother or sister,
* Allergy to any of the excipients of Granocyte,
* History of severe drug allergy, anaphylactic allergic shock or angioedema
* Pre-existing splenomegaly
* Obesity (BMI 30),
* Autoimmune diseases,
* Alcohol and drug abuse, drug abuse
* Blood donation within 2 months prior to inclusion
* Volunteer registered or wishing to register on the bone marrow donor list,
* Sickle cell disease,
* Presence of positive virological markers (anti HIV1 and 2, HTLV1 and 2, anti-HCV, anti-HBS, anti-HBC serologies), active syphilis,
* Rheumatoid arthritis,
* Anticoagulant therapy,
* History of cutaneous vasculitis
* Phenylketonuria,
* Subject on exclusion from another study
* Subject under administrative or judicial supervision
* Subject who would receive more than 4500 euros in compensation due to participation in other research in the 12 months preceding this study,
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05594433
Study Brief:
Protocol Section:
NCT05594433