Important Information
If you are interested in applying for this study, please:
- read the study description.
- 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 and share the Participant Informed Consent Form for you to read.
Study Information
NZCR is trialling an investigational medication that is being developed for the potential treatment of inflammatory bowel disease (IBD). IBD describes a group of disorders involving the inflammation of the digestive tract, including Crohn’s disease and ulcerative colitis. This can cause symptoms such as diarrhoea, rectal bleeding, abdominal pain, fatigue, and weight loss. It is estimated that 20,000 New Zealanders live with IBD.
RO7504109 is a monoclonal antibody, and it works by blocking certain white blood cells (cells that fight off infections and help treat injuries) called monocytes from getting into the bowel tissue. When these monocytes get into the bowel tissue of an IBD patient, they can cause inflammation and make it much worse. It is hoped that, by blocking monocytes from entering the bowel tissue, RO7504109 could be an effective treatment for IBD.
This study will investigate the effects of single ascending doses (SAD) and multiple ascending doses (MAD) of RO7504109 in healthy participants.
RO7504109 is an investigational drug because it has not been approved by MedSafe or other drug regulatory authorities.
This study (2024 FULL 19999) is being funded by F. Hoffmann-La Roche Ltd. and has been approved by the Health and Disability Ethics Committee.
Requirements
Healthy Males and Females
- Aged between 18 – 65 years old
- Weigh at least 50kg
- BMI (Body Mass Index) between 18 to 32 kg/m2
- Smokers/Vapers allowed
- Not currently taking any regular prescription medications
What is Involved?
Study Visits: 3 night stay + 12 clinic visits
Reimbursement: Up to $8,000 before tax
Important Documents
Important documents to download and read
Pre-screening Form
Sunrise
Pre screening for Sunrise