Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353756
Status:
UNKNOWN
Last Update Posted:
2006-10-11
First Post:
2006-07-17
Brief Title:
Phase 1 Study of Safety and Biological Effects of C326 an Inhibitor of IL-6 in Crohns Disease
Sponsor:
Avidia
Organization:
Avidia
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 Crohns 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 Crohns 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 Crohns Disease
effects on symptoms of Crohns 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 Crohns Disease
effects on symptoms of Crohns disease
Participants may receive either a single or several intravenous infusions of C326 or matching placebo
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