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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT03837093
Eligibility Criteria:
Inclusion Criteria:
* Without any chronic diseases diagnosed (including allergies);
* Effective contraception\> 2 weeks before the first administration of the experimental drug or its placebo and β-hCG negative at the verification of the selection criteria;
* Affiliated to a social security system;
* Free, informed and written consent, signed by the subject and the investigator, before any action required by the research.
* Not taking any treatment
Exclusion Criteria:
* Subject in a period of exclusion of participation in other biomedical research;
* Participation in another research ≤ 1 month and during the study except for research Transimmunom (Non-interventional research involving the human person);
* known antecedents of autoimmune diseases;
* Hypersensitivity to any of the excipients of the investigational drug (mannitol, sodium laurilsulfate, monosodium phosphate dihydrate, disodium phosphate dihydrate);
* Evolutionary infection requiring treatment;
* Viral infection and benign infection less than 2 months old;
* Venous capital not allowing blood samples;
* Pregnant or lactating women;
* Men and women of childbearing potential without effective contraception during the study;
* Live attenuated virus vaccination in the month prior to inclusion or during the study;
* Surgical intervention ≤ 2 months or planned during the study;
* Psychiatric pathology or drug addiction that may impair ability to comply with protocol requirements or give informed consent;
* Presence or history of cancer that has not been cured for less than 5 years, except in situ cervical cancer, or basocellular cancer;
* Subject under a legal protection measure.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03837093
Study Brief:
Protocol Section:
NCT03837093