Trial | NCT00353756  Report issue

Title

Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn's Disease
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    AMG220 ...

  • Study Participants

    52
The purpose of this study is to determine whether C326, a new inhibitor of IL-6, is safe in patients with Crohn's disease.
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.
Study Started
Sep 30
2006
Study Completion
Sep 30
2007
Last Update
Oct 11
2006
Estimate

Drug C326, IL-6 Inhibitory Avimer protein

Criteria 

Inclusion Criteria:

Adults 18 - 65
Stable, moderately active Crohn's Disease
Otherwise in generally good health

Exclusion Criteria:

Variety of concurrent medical conditions
Various concomitant medications
No Results Posted