Crohn's Disease
Conditions
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.
Interventions
DRUGC326, IL-6 Inhibitory Avimer protein
Sponsors
Avidia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluations | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | — |
| Biomarker changes -- IL-6, CRP and other acute phase reactants | — |
| Crohn's Disease Activity Index (CDAI) | — |
Countries
Australia
Contacts
Primary ContactGabrielle McKee
Outcome results
None listed