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

Phase 1

• Conditions: Crohn's Disease

• Registration Number: NCT00353756
• Lead Sponsor: Avidia

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.

Study Timeline

• Study First Submitted: 2006-07-17
• Study First Submitted QC: 2006-07-17
• Study First Posted: 2006-07-19
• Status Verified: 2006-09
• Study Start: 2006-09
• Last Update Submitted: 2006-10-10
• Last Update Posted: 2006-10-11
• Study Completion: 2007-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety evaluations

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics
Biomarker changes -- IL-6, CRP and other acute phase reactants
Crohn's Disease Activity Index (CDAI)

Trial Locations

Locations (2)

Center for Clinical Studies; 🇦🇺 Melbourne, Victoria, Australia

QPharm; 🇦🇺 Brisbane, Queensland, Australia