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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
QPharm
Brisbane, Queensland, Australia
RECRUITINGCenter for Clinical Studies
Melbourne, Victoria, Australia
RECRUITINGSafety evaluations
Pharmacokinetics
Biomarker changes -- IL-6, CRP and other acute phase reactants
Crohn's Disease Activity Index (CDAI)
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