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

Brief Summary

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Detailed Clinical Trial 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 Used in this Clinical Trial

  • Drug: C326, IL-6 Inhibitory Avimer protein

Outcome Measures for this Clinical Trial

Primary Measures

  • Safety evaluations

Secondary Measures

  • Pharmacokinetics
  • Biomarker changes — IL-6, CRP and other acute phase reactants
  • Crohn’s Disease Activity Index (CDAI)

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Avidia
  • Overall Official(s)
    • Lee Min Yap, MD, Principal Investigator, Alfred Hospital, Melbourne, Australia
    • Graham Radford-Smith, MD, Principal Investigator, Royal Brisbane and Womens Hospital, Brisbane, Australia
  • Overall Contact(s)
    • Gabrielle McKee, 61 (0)7 3331 3933, Gabrielle.McKee@clinetserv.com

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00353756