Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411723
Status:
UNKNOWN
Last Update Posted:
2009-02-20
First Post:
2006-12-12
Brief Title:
Safety Study of RTL1000 Recombinant T Cell Receptor Ligand in Subjects With Multiple Sclerosis
Sponsor:
Artielle ImmunoTherapeutics
Organization:
Artielle ImmunoTherapeutics
Study Overview
Official Title:
Phase 1 Safety Study of RTL1000 Recombinant T Cell Receptor Ligand in Subjects With Multiple Sclerosis
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 bodys immune system responds after administration of RTL1000 and the other to test blood samples to see how the body absorbs and eliminates the RTL1000
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 bodys immune system responds after administration of RTL1000 and the other to test blood samples to see how the body absorbs and eliminates the RTL1000
Detailed Description:
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None