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

Avidia

Status and phase: Unknown; Phase 1

Conditions: Crohn's Disease

Treatments: Drug: C326, IL-6 Inhibitory Avimer protein

Study type: Interventional

Funder types: Industry

Identifiers

NCT00353756

AV14-C001

Details and patient eligibility

About

The purpose of this study is to determine whether C326, a new inhibitor of IL-6, is safe in patients with Crohn's disease.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind