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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 Description

New Zealand Clinical Research is trialling an investigational medication that is being developed for the treatment of pulmonary arterial hypertension (PAH). PAH is a rare and progressive (gets worse over time) disorder where individuals have high blood pressure that affects arteries (blood vessels) in the lungs and in the heart. This slows the blood flow through the lungs and causes high blood pressure in the lungs, which puts pressure on the heart. The extra pressure on the heart causes the heart muscle to become weak and fail.

The current standard treatment for PAH only remains in the body for a short period of time, which means patients have to inhale (breathe in) treatment every 2 hours whilst awake. This limits the effectiveness as people often aren’t consistent with the treatment and it impacts their quality of life. There are also many unpleasant side effects. Globally around 50-70 million people have PAH, in New Zealand there are currently 75 people accessing PAH treatments.

L608 is an investigational inhalation solution that should lead to a slower release of current standard of care (Iloprost). Iloprost causes smaller blood vessels to open, to improve blood flow. It is hoped that, by slowing the release of the medication, the patients will have to inhale the drug less often. It is hoped that this will optimise the drug exposure over a longer period of time and reduce some of the side effects caused by the current standard of care (Iloprost). This may improve treatment options for PAH.

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

This study (2024 FULL 20305) is being funded by Pharmosa Biopharm Inc. and has been approved by the Health and Disability Ethics Committee (HDEC).

Requirements

Healthy Males and Females:

  • Be aged 18 – 65 years.
  • Are in good health.
  • Weigh at least 50kg.
  • Have a BMI (Body Mass Index) between 18.5 kg/m2 – 32.0 kg/m2
  • Not currently taking any regular prescription medications for your health (e.g., anti-depressants)
  • Have not smoked more than 100 cigarettes in your lifetime and have not used any nicotine containing products within 3 months prior to screening.
  • Do not have a history of asthma, sleep apnea, chronic obstructive pulmonary disease, pulmonary fibrosis, bronchiectasis, bronchospasm, and/or reactive airway.

What is Involved?

Study Visits: 3-night stay + 2 clinic visits
Reimbursement: Up to $3,000 before tax

Important Documents

Important documents to download and read

Pre-screening Form

Dawn

Pre screening for Dawn

Personal details

Please provide your name, email and phone number so we can contact you. If you have not registered with us before, please REGISTER HERE.

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?
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 a history of asthma, sleep apnea, chronic obstructive pulmonary disease, pulmonary fibrosis, bronchiectasis, bronchospasm, and/or reactive airway?
Do you have any history of allergies, hay fever, food or drug allergies etc that you are aware of?
Do you have any history of medical conditions relating to:(Required)
Have you taken any prescription, vitamins, supplements, pharmacy medication or over the counter medications in the last 7 days?
Have you had any surgeries in the last 3 months or do you have any planned for the next 6 months?
Have you donated blood or plasma in the last 2 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.
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. 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.