Important Information
If you are interested in applying for this study, please:
- Read the study description and study information document.
- Review the Visit Planner dates in your location and confirm that you are available for the stated dates.
- If you have not yet registered with us, click on the ‘Register’ button at the top of this page and answer the questions.
- If you have already registered with us, answer the pre-screening questions listed below and submit your interest.
We will then contact you to check your suitability.
Study Information
New Zealand Clinical Research is trialling an investigational medicine that could help people with inflammatory bowel disease.
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 and 5 million people worldwide, are affected by these 2 forms of IBD.
Vedolizumab (Entyvio) is currently used as treatment in New Zealand for moderate to severe CD and UC. The Sponsor, Alvotech has developed an investigational drug designed to be similar to Vedolizumab, called AVT80. AVT80 is a monoclonal antibody that targets an immune cell protein (α4β7 integrin) to stop it from binding to a gut protein (MAdCAM-1) found in the gastrointestinal (GI) cells. The interaction between the immune cell protein and gut protein is thought to be important in diseases such as CD or UC. It is hoped that by reducing this interaction, AVT80 can reduce migration of immune cells into the GI tract thereby reducing inflammation found in the GI tract.
This is an investigational medicine because it has not been approved by MedSafe or other drug regulatory authorities.
This study (2024 FULL 21681) is being funded by Alvotech Swiss AG and has been approved by the Northern B Health and Disability Ethics Committee.
Requirements
Healthy Males and Females
- Aged between 18 – 55 years
- Weigh between 50 – 90 kgs
- BMI (Body Mass Index) between 17 – 32 kg/m²
- Smokers/Vapers allowed
- Not currently taking any regular prescription medications
What is Involved?
Study Visits: 3-night stay + 25 clinic visits
Reimbursement: Up to $7,000 before tax