Crohn's Disease Clinical Trial
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 Crohn’s Disease
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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