Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192465
Status:
COMPLETED
Last Update Posted:
2009-01-29
First Post:
2005-09-13
Brief Title:
Trial to Evaluate the Safety Tolerability and Pharmacokinetics of MEDI-524 in Healthy Adults
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Phase I Open-Label Dose-Escalation Study to Evaluate the Safety Tolerability and Pharmacokinetics of MEDI-524 NUMAX TM a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus RSV in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2009-01
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:
To provide safety tolerability pharmacokinetic and immunogenicity data for MEDI-524 administered initially as a single dose to healthy adults in a dose escalation safety study before testing in the targeted pediatric population
Detailed Description:
None
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