Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-02-17 @ 11:06 PM
Study NCT ID:
NCT00116168
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2005-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528
Sponsor:
MedImmune LLC
Organization:
Study Overview
Official Title:
A Phase I, Open Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528, a Humanized Monoclonal Anti-Interleukin-9 Antibody, in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2013-10
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:
A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.
Detailed Description:
The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single SC doses of MEDI-528 administered to healthy adult volunteers in four dose groups.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: