Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299819
Status:
COMPLETED
Last Update Posted:
2007-12-18
First Post:
2006-03-06
Brief Title:
Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus SLE
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Phase I Randomized Double-Blind Placebo Controlled Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545 a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes in Patients With Systemic Lupus Erythematosus SLE
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
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:
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo over a dose escalation range of 03-30 mgkg in adult patients with SLE and who are receiving 20 mgday or less of prednisone orally or an equivalent dose of another oral corticosteroid
Detailed Description:
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo over a dose escalation range of 03-30 mgkg in adult patients who have SLE and who are receiving 20 mgday or less of prednisone orally or an equivalent dose of another oral corticosteroid
The secondary objective of this study is to describe the pharmacokinetics and potential immunogenicity of MEDI-545
The secondary objective of this study is to describe the pharmacokinetics and potential immunogenicity of MEDI-545
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