Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis
Recruitment status was: Active, not recruiting
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.
|Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting||Drug: RTL1000 (recombinant T cell receptor ligand) Drug: RTL1000 Placebo||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase 1 Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis|
- Adverse events, safety, laboratory parameters, vital signs, ECG and physical exam results. Disease parameters (neurologic exam, EDSS, 25 foot timed walk, 9-hole PEG test, MRI). Antibodies to drug. [ Time Frame: Day 28 ]
|Study Start Date:||December 2006|
|Estimated Study Completion Date:||May 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
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.
|Placebo Comparator: 2||
Drug: RTL1000 Placebo
Dosage form: IV infusion. Dosage: Same volume as Experimental. Frequency: Single dose. Duration: 1 - 2 hours.
This is a double-blind, placebo-controlled treatment protocol with up to six treatment cohorts, each of which receives a single intravenous infusion of an escalating dose of RTL1000. Each dosing group will have six subjects: two who will receive a single dose of placebo and four who will receive a single dose of RTL1000. Subjects are observed in the hospital during the infusion and for 24 hours afterward, and are then followed weekly for 28 days and at 1 and 2 months post-infusion to evaluate safety parameters.
Objectives of the study are to evaluate the safety profile of a single dose of RTL1000 administered by intravenous infusion, to evaluate the pharmacokinetic profile of RTL1000 in a subset of subjects, and to evaluate the feasibility of assessing immunologic parameters in a subset of subjects.
Endpoints include vital signs, electrocardiogram and physical examination results, adverse events, and serious adverse events and safety laboratory parameters (e.g., clinical chemistries and hematology values). Disease parameters, such as neurological findings, expanded disability status scale (EDSS), 25-ft timed walk, 9-hole peg test, and magnetic resonance imaging (MRI) will be measured to ensure that study treatment does not make disease worse. Subjects will also be tested at the beginning and end of the study for antibodies to the drug and its components.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411723
|United States, Connecticut|
|Yale Center for MS Treatment and Research|
|New Haven, Connecticut, United States, 06510|
|United States, Indiana|
|Indiana University, Dept. of Neurology|
|Indianapolis, Indiana, United States, 46202|
|United States, Kansas|
|University of Kansas Medical Center, Landon Center on Aging|
|Kansas City, Kansas, United States, 66160|
|United States, Maryland|
|University of Maryland School of Medicine|
|Baltimore, Maryland, United States, 21201|
|United States, Oregon|
|MS Center of Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|United States, Washington|
|MS Center at Evergreen|
|Kirkland, Washington, United States, 98034|
|Principal Investigator:||Jana Preiningerova, M.D.||Yale Center for MS Treatment and Research|
|Principal Investigator:||David Mattson, M.D., Ph.D.||University of Indiana, Department of Neurology|
|Principal Investigator:||Sharon Lynch, M.D.||University of Kansas Medical Center, Landon Center on Aging|
|Principal Investigator:||Christopher Bever, Jr., M.D., M.B.A.||University of Maryland|
|Principal Investigator:||Theodore R Brown, M.D.||MS Center at Evergreen|
|Principal Investigator:||Vijayshree Yadav, M.D.||MS Center of Oregon Health and Science University|