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 Candidtes
- 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)