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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00353756
Recruitment Status : Unknown
Verified September 2006 by Avidia.
Recruitment status was:  Recruiting
First Posted : July 19, 2006
Last Update Posted : October 11, 2006
Sponsor:
Information provided by:
Avidia

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: C326, IL-6 Inhibitory Avimer protein Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : September 2006
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease




Primary Outcome Measures :
  1. Safety evaluations

Secondary Outcome Measures :
  1. Pharmacokinetics
  2. Biomarker changes -- IL-6, CRP and other acute phase reactants
  3. Crohn's Disease Activity Index (CDAI)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353756


Contacts
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Contact: Gabrielle McKee 61 (0)7 3331 3933 Gabrielle.McKee@clinetserv.com

Locations
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Australia, Queensland
QPharm Recruiting
Brisbane, Queensland, Australia
Principal Investigator: Graham Radford-Smith, MD         
Australia, Victoria
Center for Clinical Studies Recruiting
Melbourne, Victoria, Australia
Principal Investigator: Lee Min Yap, MD         
Sponsors and Collaborators
Avidia
Investigators
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Principal Investigator: Lee Min Yap, MD Alfred Hospital, Melbourne, Australia
Principal Investigator: Graham Radford-Smith, MD Royal Brisbane and Womens Hospital, Brisbane, Australia
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ClinicalTrials.gov Identifier: NCT00353756    
Other Study ID Numbers: AV14-C001
First Posted: July 19, 2006    Key Record Dates
Last Update Posted: October 11, 2006
Last Verified: September 2006
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases