Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT01258205
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2010-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease, and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease
Status:
COMPLETED
Status Verified Date:
2021-05
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 purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: