Crohn's DiseasePhase 1NCT00353756
Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn's Disease
A Phase 1 study testing C326, IL-6 Inhibitory Avimer protein in people with Crohn's Disease, run by Avidia at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- C326, IL-6 Inhibitory Avimer protein
- How many people
- 52 participants
- Where
- 2 sitesAustralia
- Study dates
- Sep 2006to Sep 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 - 65
- Stable, moderately active Crohn's Disease
- Otherwise in generally good health
Who cannot join
- Variety of concurrent medical conditions
- Various concomitant medications
Trial locations and contacts
2 sites in 1 country.
Australia2 sites, 2 recruiting
- Recruiting
QPharm
Brisbane, Queensland
Graham Radford-Smith, MD
- Recruiting
Center for Clinical Studies
Melbourne, Victoria
Lee Min Yap, MD
About this study
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
The purpose of this study is to determine whether C326, a new inhibitor of IL-6, is safe in patients with Crohn's disease.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- C326, IL-6 Inhibitory Avimer protein
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C326, IL-6 Inhibitory Avimer proteinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluations
Secondary outcomes (3)
Pharmacokinetics
Biomarker changes -- IL-6, CRP and other acute phase reactants
Crohn's Disease Activity Index (CDAI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startSep 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 52 participants
Sponsor and investigators
- Lead sponsor
- Avidia
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lee Min Yap, MD, Principal investigator, Alfred Hospital, Melbourne, AustraliaGraham Radford-Smith, MD, Principal investigator, Royal Brisbane and Womens Hospital, Brisbane, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353756
- Sponsor's protocol ID
- AV14-C001
- Status last verified
- Sep 2006
- First submitted
- 17 Jul 2006
- Last updated
- 11 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00353756
- Acronym / sponsor ID
- AV14-C001
- Conditions
- Crohn's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants
- Lead sponsor
- AvidiaIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Sep 2007
- First posted
- 19 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 - 65
- Stable, moderately active Crohn's Disease
- Otherwise in generally good health
Key exclusion criteria (2 listed)
- Variety of concurrent medical conditions
- Various concomitant medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C326, IL-6 Inhibitory Avimer protein | Drug | – |
Primary outcome
Safety evaluations
3 secondary outcomes
Pharmacokinetics
Biomarker changes -- IL-6, CRP and other acute phase reactants
Crohn's Disease Activity Index (CDAI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Min Yap, MD principal investigator
Alfred Hospital, Melbourne, Australia
Graham Radford-Smith, MD principal investigator
Royal Brisbane and Womens Hospital, Brisbane, Australia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C326, IL-6 Inhibitory Avimer protein in people with Crohn's Disease, run by Avidia at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabrielle McKee (61 (0)7 3331 3933, Gabrielle.McKee@clinetserv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluations. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2006.