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

Primary Purpose

Crohn's Disease

Status
Unknown status
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
C326, IL-6 Inhibitory Avimer protein
Sponsored by
Avidia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • QPharmRecruiting
  • Center for Clinical StudiesRecruiting

Outcomes

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)

Full Information

First Posted
July 17, 2006
Last Updated
October 10, 2006
Sponsor
Avidia
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1. Study Identification

Unique Protocol Identification Number
NCT00353756
Brief Title
Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Avidia

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
52 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
C326, IL-6 Inhibitory Avimer protein
Primary Outcome Measure Information:
Title
Safety evaluations
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Title
Biomarker changes -- IL-6, CRP and other acute phase reactants
Title
Crohn's Disease Activity Index (CDAI)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabrielle McKee
Phone
61 (0)7 3331 3933
Email
Gabrielle.McKee@clinetserv.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Min Yap, MD
Organizational Affiliation
Alfred Hospital, Melbourne, Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Graham Radford-Smith, MD
Organizational Affiliation
Royal Brisbane and Womens Hospital, Brisbane, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
QPharm
City
Brisbane
State/Province
Queensland
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graham Radford-Smith, MD
Facility Name
Center for Clinical Studies
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Min Yap, MD

12. IPD Sharing Statement

Learn more about this trial

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

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