Healthy Volunteers
Conditions
Keywords
Low dose of IL-2, Healthy volunteers, Kinetic study
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 indicates a lack of Tregs. Our team has discovered that low-dose interleukin-2 (ld-IL2) activates and specifically increases Tregs in humans and thus may improve AID. Exploiting this potential requires i) to better target the dose with the best benefit / risk ratio and also ii) to better understand the mechanism of action of this molecule through clinical trials of ld-IL2 in progress, including in type 1 diabetes, multiple sclerosis and systemic lupus erythematosus. During these clinical trials, a very thorough immunological follow-up is carried out in order to discover biomarkers of treatment efficacy. Exploitation of these results will benefit both the cross-analysis of the effects of IL-2 in these 3 diseases with distinct pathophysiologies, but also very importantly a comparison with the effects of ld-IL2 at the healthy volunteer. These analyzes should make it possible to define the most effective dose of IL-2.
Interventions
DRUGILT101
Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks
DRUGPlacebo
Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks
Sponsors
Iltoo Pharma
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation of Tregs(in (expressed in % of CD4 and total) | from Day 1 to Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| numbers of different circulating immune populations | baseline to Day 60 |
| levels of serum cytokine(pg) | from baseline to Day 60 |
| levels of serum chemokine | from baseline to Day 60 |
| AUC corresponding to the évolution of residual values of tregs/CD4+ | Day 5 to Day 60 |
| adverse events, anti IL-2 autoantibodies | from baseline to Day 60 |
| levels of serum anti-IL-2 autoantibodies | from baseline to Day 60 |
| composition of the intestinal microbiota | from baseline to Day 60 |
Countries
France
Outcome results
None listed