Phase 1 Study of Safety and Biological Effects of C326, a... | NCT00353756

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

NCT00353756

Sponsor

Avidia

Status

Unknown status

Last Update Posted

Oct 11, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Crohn's Disease

Interventions

C326, IL-6 Inhibitory Avimer protein

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Sep 2007

First Submitted Date

Jul 17, 2006

First Submission Date that Met QC Criteria

Jul 17, 2006

First Posted Date

Jul 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2006

Last Update Posted Date

Oct 11, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
C326, IL-6 Inhibitory Avimer protein	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety evaluations

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gabrielle McKee	Contact	61 (0)7 3331 3933		Gabrielle.McKee@clinetserv.com

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
QPharm	Recruiting	Brisbane	Queensland		Australia

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided