Clinical Trials Logo
  1. Home
  2. Crohn's Disease
  3. NCT00353756
  4. Details
NCT00353756 Clinical Trial

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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00353756
Other study ID # AV14-C001
Secondary ID
Status Recruiting
Phase Phase 1
First received July 17, 2006
Last updated October 10, 2006
Start date September 2006
Est. completion date September 2007

Study information
Verified date September 2006
Source Avidia
Contact Gabrielle McKee
Phone 61 (0)7 3331 3933
Email Gabrielle.McKee@clinetserv.com
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 52
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• C326, IL-6 Inhibitory Avimer protein

Locations
Country Name City State
Australia QPharm Brisbane Queensland
Australia Center for Clinical Studies Melbourne Victoria

Sponsors (1)
Lead Sponsor Collaborator
Avidia

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety evaluations
Secondary Pharmacokinetics
Secondary Biomarker changes -- IL-6, CRP and other acute phase reactants
Secondary Crohn's Disease Activity Index (CDAI)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03815851 - Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery N/A
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Completed NCT02883452 - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis Phase 1
Recruiting NCT04777656 - Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. Phase 3
Terminated NCT03017014 - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Recruiting NCT06053424 - Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease Phase 1
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A
Terminated NCT02882841 - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients N/A
Completed NCT03010787 - A First Time in Human Study in Healthy Volunteers and Patients Phase 1
Terminated NCT02417974 - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) Phase 2
Completed NCT02542917 - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT02193048 - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Completed NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
Completed NCT01958827 - A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease Phase 3