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

This study is currently recruiting participants.

Verified by Avidia, September 2006

First Received: July 17, 2006 Last Updated: October 10, 2006 History of Changes

Sponsored by:	Avidia
Information provided by:	Avidia
ClinicalTrials.gov Identifier:	NCT00353756

Purpose

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	Intervention	Phase
Crohn's Disease	Drug: C326, IL-6 Inhibitory Avimer protein	Phase I

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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

Further study details as provided by Avidia:

Primary Outcome Measures:

Safety evaluations

Secondary Outcome Measures:

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

Estimated Enrollment:	52
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353756

Contacts

Contact: Gabrielle McKee

61 (0)7 3331 3933

Gabrielle.McKee@clinetserv.com

Locations

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

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

More Information

No publications provided

Study ID Numbers:	AV14-C001
Study First Received:	July 17, 2006
Last Updated:	October 10, 2006
ClinicalTrials.gov Identifier:	NCT00353756 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Crohn's Disease
Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Ileal Diseases

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis
Crohn Disease

Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Ileal Diseases

ClinicalTrials.gov processed this record on May 07, 2009