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
ALXN1920 is being developed for the treatment of kidney diseases caused by an over-active immune system (also called complement-mediated kidney disease). These types of kidney diseases are rare and are caused when a part of the immune system becomes overly active. As a result, the body initiates an inflammatory response that leads to kidney damage, resulting in protein in the urine (proteinuria) and lowered kidney function.
ALXN1920 works by providing regulation of the complement immune system in the kidneys, reducing inflammation and proteinuria. It is hoped that, by reducing inflammation and proteinuria, ALXN1920 may be an effective treatment for complement-mediated kidney diseases.
The purpose of this study is to:
- Evaluate how safe and well tolerated ALXN1920 is, in healthy participants.
- Measure levels of ALXN1920 in the blood and urine over time, following a single dose.
- Measure the body’s response to a single dose of ALXN1920.
- Assess the body’s immune response to ALXN1920.
- To assess the ability of subcutaneously administered ALXN1920 to be able to be absorbed and used by the body.
- To compare the body’s response and drug levels of ALXN1920 between Japanese and non-Japanese participants.
Study Candidates
- Healthy males and females
- Aged 18 – 55 years
- Weight 50kg or more
- BMI 18 – 32 kg/m2
- Non-smokers, or smoking less than 5 cigarettes per day
- Not currently taking any regular medications for your health (e.g. anti-depressants)
What is Involved?
Study Visits: 6-night stay
Outpatient visits: 4 visits
Reimbursement: $5,000 (less tax)