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Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis

NCT00411723 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2009-02-20

No results posted yet for this study

Summary

RTL1000 is a new agent that has not been previously tested in humans. It is thought that RTL may specifically control the abnormal immune response or attack against the insulation on the nerves that occurs in multiple sclerosis.

The purpose of this study is to evaluate the possible side effects of a single intravenous dose of RTL1000 in subjects with multiple sclerosis. Some subjects will also be asked to participate in one or both of two substudies, one to test blood samples to see how the body's immune system responds after administration of RTL1000, and the other to test blood samples to see how the body absorbs and eliminates the RTL1000.

Conditions

  • Multiple Sclerosis, Chronic Progressive
  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

RTL1000 (recombinant T cell receptor ligand)

Dosage form: IV infusion. Dosage: Single dose @ 2, 6, 20, 60, 100 or 200mg. Duration: 1 - 2 hours.

DRUG

RTL1000 Placebo

Dosage form: IV infusion. Dosage: Same volume as Experimental. Frequency: Single dose. Duration: 1 - 2 hours.

Sponsors & Collaborators

  • Artielle ImmunoTherapeutics

    lead INDUSTRY

Principal Investigators

  • Jana Preiningerova, M.D. · Yale Center for MS Treatment and Research

  • David Mattson, M.D., Ph.D. · University of Indiana, Department of Neurology

  • Sharon Lynch, M.D. · University of Kansas Medical Center, Landon Center on Aging

  • Christopher Bever, Jr., M.D., M.B.A. · University of Maryland, Baltimore

  • Theodore R Brown, M.D. · MS Center at Evergreen

  • Vijayshree Yadav, M.D. · MS Center of Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-02-28
Completion
2009-05-31

Countries

  • United States

Study Locations

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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 NCT00411723 on ClinicalTrials.gov