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
New Zealand Clinical Research is trialling an investigational medication that is being developed for the treatment of Haemophilia A.
NXT007 is being developed for the treatment of Haemophilia A (HA). HA is a rare genetic blood clotting disorder. HA is linked to a gene mutation (mistake) in a gene resulting in a lowered amount of clotting factor VIII (FVIII) which is an important component in blood clotting (coagulation). People with HA bleed for a longer period both internally and externally, leading to organ and tissue damage. Globally around 80-85% of haemophilia cases are HA, and about 500 people in New Zealand have HA. Most people affected with HA are male due to the X-linked gene that gets passed down genetically.
NXT007 is a monoclonal antibody that binds to certain blood clotting factors and mimics the function of FVIII. FVIII helps to clot a person’s blood. NXT007 acts similarly to another monoclonal antibody called emicizumab, which is approved for use in patients both globally and within New Zealand. It is hoped that NXT007 will be more effective than emicizumab.
NXT007 has been investigated in healthy participants at the same dose as this study in previous trials and is currently being investigated in people with HA. The purpose of this study is to understand the way your body processes NXT007 when a single dose of it is injected under the skin into different sites of the body (abdomen, upper arm, or thigh) or directly infused into your bloodstream and to find out if it is safe and has any effects (good or bad) on healthy participants.
It is hoped that by binding to certain blood clotting factors, NXT007 may be an effective treatment for HA.
It is an investigational drug because it has not been approved by MedSafe or other drug regulatory authorities.
This study (2023 FULL 19046) is being funded by F. Hoffmann-La Roche Ltd and has been approved by the Health and Disability Ethics Committee.
Study Candidates
- Healthy Males only
- Age 18 – 45
- Weigh 60 – 100 kg (inclusive)
- BMI 18.5 – 30 kg/m2
- Non-smokers, or smoking less than 5 cigarettes per day
- Not currently taking any medications
What is Involved?
Inpatient Stay: 2 nights in patient stay
Follow-Up: 21 follow – up visits
Reimbursement: $7,000 (less tax)