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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

Personal details

Please provide your name, email and phone number so we can contact you

Medical questions

Have you had any covid symptoms in the last 4 weeks or been in isolation?
Have you previously participated in a study with NZCR or any other organisation? Give details or leave blank if no
This study requires the use of contraception during the study. If you are in a hetereosexual relationship both partners must agree to use contraception (condoms for males | IUD, birth control or another approved form for females). Are you currently using 2 forms of contraception?
Have you received blood or plasma in the last 90 days? If yes please provide details
Any history of abnormal liver or kidney conditions?
Do you have any significant heart disease or heart related conditions/abnormalities? Do you have any family history of heart conditions?
Do you have any history of allergies, asthma, hay fever, food allergies etc that you are aware of?
Do you have any history of medical conditions relating to:(Required)
If you have none, please select the last option.
Have you taken any prescription, vitamins, supplements, pharmacy medication or over the counter medications in the last 28 days? Please include any Vaccines in the last 3 months
Have you looked at the study dates and are okay to come in those days? Indicate which group/s you are available for. This means having flexibility for more than one group increases your chances of being accepted into a group.
Pre-screening form policy(Required)
I understand that by submitting this form, NZCR will use the information for pre-screening purposes for this study. This information may be recorded on your profile to allow us to improve our process when screening you for a future study. All information provided is confidential. I also understand that by submitting this form, I will be receiving emails, texts or calls about this study. For more information, please refer to the Privacy Policy.