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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 Auckland. 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 Cystic Fibrosis (CF). CF is a genetic condition that affects multiple organs, mainly the lungs, pancreas, and digestive system. Approximately 100,000 people worldwide are affected by CF, and in New Zealand around 540 people are diagnosed with CF.

In people with CF, the cells in the body that produce mucus, sweat and digestive fluids becomes thick and sticky. The thick, sticky fluid will then block up tubes and passageways in the body which damages body organs, particularly the lungs.

The investigational medication is designed to be given inhaled as a mist (through a device called a nebuliser). It is hoped that, by directly delivering the investigational medication to the lungs, this may reduce the amount of thick fluid in the lungs, making it easier to breathe. The investigational medication may be an effective treatment for individuals diagnosed with CF that are unable to receive current CF treatment options in the market which may improve their quality of life.

This is an investigational medicine because it has not been approved by MedSafe or other drug regulatory authorities.

This study (2023 FULL 18861) is being funded by ReCode Therapeutics, Inc and has been approved by the Health and Disability Ethics Committee.

Study Candidates

  • Healthy Males and Females
    • Age 18 – 55 years old
    • Weigh 50 kg or more
    • BMI 16 – 32 kg/m2 (inclusive)
    • Non-smokers or Ex-smokers
    • Not currently taking any medications

What is Involved?

Inpatient stay: 3-night stay

Follow-up visits: 3 follow-up visits

Reimbursement: $3,100 (less tax)

Important Documents

Important documents to download and read

Pre-screening Form

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 two 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 a form of contraception?
Do you have any history of allergies, asthma, hay fever, food or drug allergies etc that you are aware of?
The study does not accept any current smokers. Have you used any nicotine or tobacco containing products in the last 6 months?
Do you have any history of medical conditions relating to:
Do you have any history of cancer?
Do you have any history of abnormal blood pressure measurements or any history or current heart disease or heart related conditions/abnormalities?
Have you taken any prescription, vitamins, supplements, pharmacy medication or over the counter medications in the last 14 days?
Have you donated blood or plasma in the last few months?
If unsure please note down what vaccines you have had in the last month and when.
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.
Just to inform you, that you come in for screening at risk. There is no payment for the screening visit, and you may not be offered a position on the study if the group fills up, or you may only be offered a position as a back-up. It is not guaranteed that you will get a full position on the study as it depends on your results as well. Are you comfortable with this?
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 (https://www.nzcr.co.nz/privacy-policy/).