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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
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/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
Gabrielle.McKee@clinetserv.com
Contact person for scientific queries

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