drugset / Trial / NCT00411723
Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2006-12
- Primary completion
- 2009-02
- Completion
- 2009-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RTL1000 | Protein / enzyme biologic | 2 mg | Intravenous |
| Subject | RTL1000 | Protein / enzyme biologic | 6 mg | Intravenous |
| Subject | RTL1000 | Protein / enzyme biologic | 20 mg | Intravenous |
| Subject | RTL1000 | Protein / enzyme biologic | 60 mg | Intravenous |
| Subject | RTL1000 | Protein / enzyme biologic | 100 mg | Intravenous |
| Subject | RTL1000 | Protein / enzyme biologic | 200 mg | Intravenous |