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

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:

Secondary Outcome Measures:

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

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

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

Study placed in the following topic categories:

Digestive System Diseases

Gastrointestinal Diseases

Crohn Disease

Inflammatory Bowel Diseases

Gastroenteritis

Intestinal Diseases

ClinicalTrials.gov processed this record on November 03, 2008

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