Important Information
Please note, we need you to ….
- Read the important documents for this study
- If you are interested, look at the dates that this study is being run (cohort visit planners) and reply to our email (don’t re-register online) to let us know which cohort(s) you are available for
- We will ring you to check your suitability and provide further information about the study
- We will make you a screening appointment at NZCR Christchurch. You will need to attend at the scheduled time if you wish to take part in the study
Study Information
New Zealand Clinical Research is trialling an investigational medication that is being developed for the treatment of Crohn’s disease and ulcerative colitis.
Crohn’s disease (CD) and ulcerative colitis (UC) are 2 main forms of inflammatory bowel disease (IBD) that causes inflammation in different areas of the digestive tract. Inflammation of the digestive tract often leads to abdominal pain, severe diarrhoea, fatigue, weight loss and malnutrition. In New Zealand, approximately 20,000 people are affected by these 2 forms of IBD.
Vedolizumab (Entyvio) is currently used as treatment for moderate to severe CD and UC. The Sponsor, Alvotech has developed an investigational drug designed to be similar to Vedolizumab, called AVT16. AVT16 is a monoclonal antibody that targets a gut protein (α4β7 integrin) found in the gastrointestinal (GI) cells The interaction between the gut protein and gut immune cells is thought to be important in diseases such as CD or UC. It is hoped that by reducing this interaction, AVT16 can reduce the inflammation found in the GI tract through reducing the migration of gut immune cells in the GI tract.
It is an investigational drug because it has not been approved by MedSafe or other drug regulatory authorities.
Study Candidates
- Be aged 18 – 55 years.
- Are in good health.
- Weigh between 50-90kg
- Have a BMI (Body Mass Index) between 17.0 kg/m2 – 30.0 kg/m2
- Not currently taking any regular prescription medications for your health (e.g., anti-depressants)
- Non smokers, or smoking less than 10 cigarettes a week
What is Involved?
Study Visits: 3 night stay + 25 outpatient appointments