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Hauraki Asthma Study Auckland

Auckland

We are looking for adults aged 18–65 years with mild-to-moderate asthma to take part in a clinical research study. The study is testing an investigational medication to assess its safety and its behaviour in the body.

Description

What to expect

Study details

Ages

18-65 years old

Duration

14 clinic visits over 10 months

Compensation

Eligible participants will be reimbursed for their time and travel costs

Eligibility Criteria

  • Are between the ages of 18 and 65 years old 
  • Have documented diagnosis of asthma for at least a year
  • Asthma is considered mild to moderate
  • Have a BMI between 18–35 kg/m²
  • Are willing to use effective contraception during and after the study

Locations

Auckland

Description

Study Aim

The primary purpose is to assess the safety and tolerability as well as evaluate the effect of multiple doses of PRA-216 compared to placebo in reducing the level of inflammation in the airways of participants with asthma. 

What’s involved

  • Screening period up to 4 weeks
  • Follow‑up visits for health checks and blood tests
  • Study duration: up to 310 days
  • Procedures include physical exams, vital signs, ECGs, blood tests, spirometry and FeNO measurements

About the Investigational Medication

What is PRA‑216?
PRA‑216 is a type of protein-based medicine called an antibody. Antibodies are natural proteins your body uses to fight infections, but scientists can also design specialised antibodies to target specific signals in the body.

This medicine is being developed to block two signals that play a role in inflammation:

  • TSLP (thymic stromal lymphopoietin)
  • IL‑4 receptor alpha (IL‑4Rα)

These signals are involved in allergic and asthma-related inflammation. By blocking them, PRA‑216 might help reduce inflammation - but this is still being studied.

Why is it investigational?
It has never been used in the asthmatic population in this combination.

How is it given?

  • As an injection under the skin (subcutaneous).
  • Some participants will receive a placebo (a dummy treatment that looks the same but has no active medicine) so researchers can compare results. 

What to expect

About The Study

Taking part in the study involves firstly meeting with the research Doctor to find out more about your health and to see if the study is right for you.  If you wish to take part and are eligible, we would like to see you for 14 clinic visits over approximately 10 months. 

During visits, we conduct health checks that may include physical examinations and blood tests. We want to ask you questions about your general health and your experience throughout the study. Other procedures include: 

  • Informed consent
  • Demographics, medical history, prior medications
  • Height and weight
  • Vital signs
  • ECG’s
  • Clinical safety labs (haematology, chemistry, coagulation, urinalysis)
  • Serology (HIV, HBV, HCV)
  • Pregnancy test (blood for WOCBP)
  • Follicle Stimulating Hormone (FSH) for post-menopausal confirmation
  • Drugs of abuse screen
  • Spirometry test to see how well your lungs work
  • Oscillometry test to measure how easily air moves through your airways
  • FeNO measurement to test for airway inflammation
  • Blood samples for PD biomarkers (baseline)

You would receive the potential new medication or a placebo (looks like the investigational medicine but contains no active medication). For every  1 participant who receives the study drug, one will receive a placebo.  

The study medication is administered subcutaneously (under the skin). 

Why Join this Clinical Research Study?

Taking part may help advance scientific knowledge and contribute to the development of new treatment options for people with asthma in the future.

Other reasons to participate:

  • Health monitoring by highly specialised NZ Doctors and Nurses
  • Study care and medication are provided free of charge
  • Participants are compensated for their time and travel

 

Your privacy is important, and all personal information will be kept strictly confidential.

Apply now

Fill out your details, and our team will be in touch to discuss your potential involvement in this study and answer any questions you may have.

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