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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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C326, IL-6 Inhibitory Avimer protein

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Lee Min Yap, MD

Role: PRINCIPAL_INVESTIGATOR

Alfred Hospital, Melbourne, Australia

Graham Radford-Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Brisbane and Womens Hospital, Brisbane, Australia

Locations

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QPharm

Brisbane, Queensland, Australia

Site Status RECRUITING

Center for Clinical Studies

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Gabrielle McKee

Role: CONTACT

Phone: 61 (0)7 3331 3933

Email: [email protected]

Other Identifiers

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AV14-C001

Identifier Type: -

Identifier Source: org_study_id