Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT00353756
Status:
UNKNOWN
Last Update Posted:
2006-10-11
First Post:
2006-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn's Disease
Sponsor:
Avidia
Organization:
Study Overview
Official Title:
A Placebo-Controlled, Phase 1, Single and Multiple IV Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of C326 in Adults With Crohn's Disease
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
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:
The purpose of this study is to determine whether C326, a new inhibitor of IL-6, is safe in patients with Crohn's disease.
Detailed Description:
Determination of safety is the most important goal of this first study with C326. Other goals of the study are to examine:
* pharmacokinetics (change in serum concentrations over time),
* biological activity (change in blood markers relecting activity of Crohn's Disease),
* effects on symptoms of Crohn's disease.
Participants may receive either a single or several intravenous infusions of C326 or matching placebo.
* pharmacokinetics (change in serum concentrations over time),
* biological activity (change in blood markers relecting activity of Crohn's Disease),
* effects on symptoms of Crohn's disease.
Participants may receive either a single or several intravenous infusions of C326 or matching placebo.
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?: