NCT03837093

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2019

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 6, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2021

Completed
Last Updated

December 30, 2021

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

January 17, 2019

Last Update Submit

December 10, 2021

Conditions

Healthy Volunteers

Keywords

Low dose of IL-2Healthy volunteersKinetic study

Outcome Measures

Primary Outcomes (1)

  • Variation of Tregs(in (expressed in % of CD4 and total)

    from Day 1 to Day 5

Secondary Outcomes (7)

  • AUC corresponding to the évolution of residual values of tregs/CD4+

    Day 5 to Day 60

  • 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

  • composition of the intestinal microbiota

    from baseline to Day 60

  • +2 more secondary outcomes

Study Arms (6)

dose A

EXPERIMENTAL

ILT-101

Drug: ILT101

dose B

EXPERIMENTAL

ILT-101

Drug: ILT101

dose C

EXPERIMENTAL

ILT-101

Drug: ILT101

dose D

EXPERIMENTAL

ILT-101

Drug: ILT101

dose E

EXPERIMENTAL

ILT-101

Drug: ILT101

Placebo

EXPERIMENTAL
Drug: Placebo

Interventions

ILT101DRUG

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

Also known as: low-dose IL-2
dose Adose Bdose Cdose Ddose E
PlaceboDRUG

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris

Paris, 75013, France

Location

MeSH Terms

Interventions

Interleukin-2

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • David Klatzmann, MD

    Investigation Center in Biotherapy et immunology Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris l'hopital 75013 Paris

    PRINCIPAL INVESTIGATOR

  • Roberta Lorenzon, MD

    Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

February 11, 2019

Study Start

June 6, 2019

Primary Completion

March 3, 2021

Study Completion

November 6, 2021

Last Updated

December 30, 2021

Record last verified: 2021-12

Locations

FR(1)