Status:
COMPLETED
Low-dose IL-2 to the Kinetics of Regulatory T-cell in Healthy Volunteers
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Iltoo Pharma
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and the dose-response relationship of ILT-101 to blood Tregs.
Detailed Description
In the healthy physiological state, there is homeostasis between regulatory T cells (Tregs) and effector T cells (Teffs) which is deregulated in autoimmune diseases (AID). The existence of an AID ind...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03837093
Start Date
June 6 2019
End Date
November 6 2021
Last Update
December 30 2021
Active Locations (1)
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1
Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris
Paris, France, 75013