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 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
DNTH103 is being developed for the treatment of inflammatory and autoimmune diseases (when the body’s natural immune system attacks normal cells) by targeting the ‘classical pathway’ of the complement cascade. The complement cascade is a process which helps to trigger the immune response to an infection. This cascade can be activated by three different pathways which act to treat infection and destroy the pathogen (disease causing). Whilst this complement cascade is a vital part of our body’s first line of defence against infection, in some disorders, the inflammation and immune response driven by this pathway to clear infection can become uncontrolled and promote further illness. In conditions such as inflammatory and autoimmune diseases, prolonged inflammation and self-targeting immune cells are promoters of disease, respectively.
DNTH103 works by aiming at and attaching to one of the sensors which activates the ‘classical pathway’, for which if uncontrolled, can be a cause of inflammatory and autoimmune diseases. It is hoped that by binding to this sensor, DNTH103 can prevent the over-activation of this pathway and may be an effective treatment for complement-causing inflammatory and autoimmune diseases.
Part C of this study will look at how a commercially available compound called Privigen 10% (IVIg) will affect the way in which the study drug, DNTH103, will be processed in the body. Privigen is approved by Health Medicines and Medical Device Safety Authority (MedSafe) in 11 different indications including several different disorders involving the immune system. Privigen acts to help the body’s defence (immune) system to recognise and clear foreign substances from the body.
The purpose of Part C of this study is to:
- Evaluate how safe and well tolerated DNTH103 is, in healthy participants
- Measure levels of DNTH103 in the blood over time, following a single dose (pharmacokinetics) after previous administration of an IVIg medication (Privigen 10%)
- Measure the body’s response to a single dose of DNTH103 (pharmacodynamics) after previous administration of an IVIg medication (Privigen 10%)
- Assess the body’s immune response to DNTH103
Study Candidates
- Males and females
- Aged 18 – 65 years
- Weight 45 – 100 kg
- BMI less than 34 kg/m2
- Non-smokers
- Not taking any medications
What is Involved?
SAD Part C Cohorts:
- Overnight stay: 2 x 3 night stay
- Follow up: 1 follow up phone call + at least 6 follow up visits
- Compensation: $5,500 (less tax)