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Huia Healthy Volunteers Study

Auckland

We are looking for healthy volunteers aged 18-65 to join a clinical research study investigating a potential new treatment for people with atopic dermatitis (eczema). The medication works by targeting two specific immune pathways (IL-13 and IL-31 receptor) that contribute to skin inflammation and itching.

Healthy volunteers help researchers determine if a new medicine is safe for humans and what side effects it might cause, before ever giving it to sick patients who are more vulnerable. Scientists need to understand exactly how the body processes the medicine - how quickly it's absorbed, broken down, and eliminated - which is clearest to see in people without other health conditions or medications that could interfere.

Testing in healthy people first protects patients with diseases from unknown risks, since healthy volunteers can better tolerate and recover from any unexpected effects. The data from healthy volunteers establishes the safe dosage range and provides the essential safety foundation that makes it ethical to then test the medicine in patients who might benefit from it. Without healthy volunteers taking this first step, new treatments for serious diseases like atopic dermatitis could never be developed safely.

Description

What to expect

Study details

Ages

Age 18-65

Duration

12 clinic visits over 11 months (including a 4-night inpatient stay)

Compensation

Up to $9625 (before tax)

Eligibility Criteria

  • Age 18-65
  • BMI: ≥ 18.5 and < 32.5 kg/m2
  • Weight 45-100kg
  • Non-smoker
  • Willing to use contraception

Locations

Auckland

Description

The investigational medication is a biologic medication – a type of drug made from living cells rather than synthetic chemicals. Think of it as a specialised protein designed in a laboratory to do a very specific job in your body.

The medication is designed to act like a "double blocker" to target two specific problems in atopic dermatitis (severe eczema):
1) IL-13 pathway - This normally causes skin inflammation (redness, swelling, irritation)
2) IL-31 receptor pathway - This triggers the intense itching that eczema patients experience

By blocking both pathways at once, the study medication aims to reduce both the skin inflammation AND the itching - addressing the two main symptoms that make eczema so miserable. By volunteering for this study, you may help bring a potential new treatment for people who suffer from moderate to severe eczema.

What to expect

Study Aim
The main purpose of this study is to learn about the study drug and evaluate its safety, tolerability and pharmacokinetics (how the body processes the medication) in healthy volunteers.

Reason to participate
Your involvement in this study may help advance scientific knowledge that could contribute to the development of a new medication and better treatment for people with eczema in the future.

About the study and the number of people involved
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 you are eligible, we would like to see you for 12 clinic visits over a period of around 11 months. Please note, this study requires a 4-night inpatient stay. Throughout the duration of the study, participants are required to not smoke and limit alcohol consumption. Eligible participants will be reimbursed up to $9,625 (before tax). 

At the visits, we undertake health checks which can include physical examinations and blood tests. We would like to ask you questions about your health and monitor your health throughout the study. Other procedures include:
• Vital signs
• ECG
• Overnight fasting prior to dosing
• Single IV infusion (approximately 60 minutes) of study drug or placebo
• Urine samples & pregnancy tests
• Symptom tracking, review of any side effects or health changes

You would take the potential new medication or a or placebo (looks like the investigational medicine but contains no active medication) via an IV infusion. There is only one dose of the study medication.  
** All PCRN studies undergo rigorous review processes and are approved by ethics committees and Medsafe.

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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