Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00353756




Registration number
NCT00353756
Ethics application status
Date submitted
17/07/2006
Date registered
19/07/2006
Date last updated
11/10/2006

Titles & IDs
Public title
Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn's Disease
Scientific 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
Secondary ID [1] 0 0
AV14-C001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - C326, IL-6 Inhibitory Avimer protein

Treatment: Drugs: C326, IL-6 Inhibitory Avimer protein
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety evaluations
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Pharmacokinetics
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Biomarker changes -- IL-6, CRP and other acute phase reactants
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Crohn's Disease Activity Index (CDAI)
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
- Adults 18 - 65

- Stable, moderately active Crohn's Disease

- Otherwise in generally good health
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Variety of concurrent medical conditions

- Various concomitant medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
QPharm - Brisbane
Recruitment hospital [2] 0 0
Center for Clinical Studies - Melbourne
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Avidia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00353756
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lee Min Yap, MD
Address 0 0
Alfred Hospital, Melbourne, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gabrielle McKee
Address 0 0
Country 0 0
Phone 0 0
61 (0)7 3331 3933
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00353756