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

NCT03837093 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-12-30

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteers

Interventions

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

DRUG

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

Sponsors & Collaborators

  • Iltoo Pharma

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • David Klatzmann, MD · Investigation Center in Biotherapy et immunology Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris l'hopital 75013 Paris

  • Roberta Lorenzon, MD · Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2021-03-03
Completion
2021-11-06

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03837093 on ClinicalTrials.gov