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

Healthy Volunteers Clinical Trial

— HEALTHIL-2  

Official title:

A Study of the Dose-response Relationship of Low-dose IL-2 to the Kinetics of Regulatory T-cell Response in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837093
• Other study ID #: APHP180274
• Secondary ID: 2018-004123-37ME
• Status: Completed
• Phase: Phase 1
• Start date: June 6, 2019
• Est. completion date: November 6, 2021

Study information

• Verified date: December 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 6, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ILT101
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
• Placebo
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

Locations

Country	Name	City	State
France	Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Iltoo Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of Tregs(in (expressed in % of CD4 and total)		from Day 1 to Day 5
Secondary	AUC corresponding to the évolution of residual values of tregs/CD4+		Day 5 to Day 60
Secondary	numbers of different circulating immune populations		baseline to Day 60
Secondary	levels of serum cytokine(pg)		from baseline to Day 60
Secondary	levels of serum chemokine		from baseline to Day 60
Secondary	composition of the intestinal microbiota		from baseline to Day 60
Secondary	adverse events, anti IL-2 autoantibodies		from baseline to Day 60
Secondary	levels of serum anti-IL-2 autoantibodies		from baseline to Day 60