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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT01699893
Eligibility Criteria:
Inclusion Criteria:
1. Subjects considered as healthy by the investigator based on medical history, clinical examination, laboratory results and ECG (blood sampling for laboratory assessments and ECG should be done at V0 and only after signed informed consent).
2. Subjects who, according to the investigator, can and will comply with the requirements of the protocol and are available for all scheduled visits at the investigational site.
3. Healthy male or female aged between 20 and 69 (included) years
4. Metropolitan French origin for 3 generations 5)18.5 ≤BMI ≤ 32 kg/m² (Appendix 18.6)
6)Ability to give their informed consent in writing 7)Must understand spoken and written French 8)Affiliated to the French social security or assimilated regimens 9)Registered on the French "Fichier des Volontaires se prêtant à la Recherche Biomédicale (VRB)"
Exclusion Criteria:
1. Subjects who can not participate according to their status on the registry mentioned at Art L. 1121-16 of the French Public Health Code
2. Participation in another clinical study in the last 3 months in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or medical device) or concurrent participation in another clinical study during the study period
3. Relatedness to previously recruited individuals in the study cohort
4. Travel in (sub-)tropical countries within the last 3 months
5. For women: pregnant or breastfeeding or intending to become pregnant or peri-menopausal\*
\* Peri-menopausal women as defined by menstrual irregularity: either a change in the menstrual cycle length of more than seven days (early perimenopause) or two or more missed periods with an interval of 60 days or more between periods (late perimenopause) (Stages of Reproductive Aging Workshop, STRAW)(11)
6. Any physical exercise within the last 8 hours before inclusion (V1) and before (V2)
7. Subjects following a special diet for medical reasons as prescribed by a GP or dietician (e.g. calorie restricted or weight-loss diet for significant overweight, cholesterol lowering diet or subjects suffering from any clinically diagnosed food allergy or intolerance)
8. Alcohol abuse (more than 50 g of pure ethanol per day: for example, more than 4 x 150 mL glasses of wine, more than 4 x 250 mL glasses of beer, more than 4 x 40 mL glasses of high alcohol content drinks)
9. Illicit drug use or substance abuse within 3 months prior to inclusion
10. Presence of evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to participate in the study satisfactorily.
11. Severe/chronic/recurrent pathological conditions,
12. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within the 6 months prior to the inclusion. For corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or equivalent for \> 2 weeks (inhaled and topical steroids allowed)
13. Chronic administration of NSAIDs, including aspirin: prolonged intake (\> 2 weeks) within 6 months before study or any intake within the 7 days preceding skin biopsy \[exception for low dose aspirin: maximum 250mg/daily, see 8.1\]
14. Receipt of any vaccination 3 months before the inclusion or planning to receive any vaccination during the study
15. Receipt of blood products or immunoglobulins within 3 months prior the inclusion or planning to receive blood products or immunoglobulins during the study
16. Hemoglobin measurement less than 10.0 g/dL for women and less than 11.5 g/dL for men
17. Platelet count less than 120.000/mm3
18. ALAT and/or ASAT \> 3 times the upper limit of the norm (ULN)
19. Allergy to lidocaine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
69 Years
Study:
NCT01699893
Study Brief:
Protocol Section:
NCT01699893