Low-dose IL-2 to the Kinetics of Regulatory T-cell in Healthy Volunteers (HEALTHIL-2)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: ILT101

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03837093

2-17-33 (Other Identifier)

APHP180274

MEDAECNAT-2018-11-0048 (Other Identifier)

2018-004123-37 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and the dose-response relationship of ILT-101 to blood Tregs.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 6 patient groups

dose A

Experimental group

Description:

ILT-101

Treatment:

Drug: ILT101

dose B

Experimental group

Description:

ILT-101

Treatment:

Drug: ILT101

dose C

Experimental group

Description:

ILT-101

Treatment:

Drug: ILT101

dose D

Experimental group

Description:

ILT-101

Treatment:

Drug: ILT101

dose E

Experimental group

Description:

ILT-101

Treatment:

Drug: ILT101

Placebo

Experimental group

Treatment:

Drug: Placebo