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

October 10, 2006 updated by: Avidia

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia
        • Recruiting
        • QPharm
        • Principal Investigator:
          • Graham Radford-Smith, MD
    • Victoria
      • Melbourne, Victoria, Australia
        • Recruiting
        • Center For Clinical Studies
        • Principal Investigator:
          • Lee Min Yap, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety evaluations

Secondary Outcome Measures

Outcome Measure
Pharmacokinetics
Biomarker changes -- IL-6, CRP and other acute phase reactants
Crohn's Disease Activity Index (CDAI)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avidia

Investigators

  • Principal Investigator: Lee Min Yap, MD, Alfred Hospital, Melbourne, Australia
  • Principal Investigator: Graham Radford-Smith, MD, Royal Brisbane and Womens Hospital, Brisbane, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion

September 1, 2007

Study Registration Dates

First Submitted

July 17, 2006

First Submitted That Met QC Criteria

July 17, 2006

First Posted (Estimate)

July 19, 2006

Study Record Updates

Last Update Posted (Estimate)

October 11, 2006

Last Update Submitted That Met QC Criteria

October 10, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV14-C001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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