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 Christchurch. You will need to attend at the scheduled time if you wish to take part in the study
Study Information
SGB-9768 is being developed for the treatment of complement-mediated disease. The complement system, also known as the complement cascade, is a part of the immune system that enhances (complements) immunity by providing a first line of defence to help fight against infections. However, excessive, or uncontrolled activation of the complement system can actually damage the body and result in diseases such as complement-mediated renal (kidney) disease.
SGB-9768 works by reducing the levels of protein called C3, which is involved in the activation of the complement pathway. The C3 protein plays an important role in the activation of the complement system, and a reduction in C3 is intended to help regulate the complement system and prevent any damage that would otherwise be caused by uncontrolled complement activity. It is hoped that, by reducing the levels of C3, that SGB-9768 may inhibit the activation of this specific complement pathway and be an effective treatment for complement mediated diseases such as complement mediated renal disease.
It is an investigational drug because it has not been approved by MedSafe or other drug regulatory authorities.
This study (2023 FULL 19206) is being funded by Sangene Bio New Zealand Pty Ltd., and has been approved by the Health and Disability Ethics Committee.
Study Candidates
- Healthy male or female aged 18 – 55 years
- Are in good health
- 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)
- May smoke or vape if on average 5 cigarettes or fewer per day (or equivalent, including nicotine patches, gum or snuff etc.).
What is Involved?
Study Visits: 3 – night stay
Outpatient visits: 12 visits
Reimbursement: $5,500 (less tax)