Japanese Participants

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.

The purpose of Part A 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)
Measure the body’s response to a single dose of DNTH103 (pharmacodynamics)
Assess the body’s immune response to DNTH103

Study Candidates

Males and females
- Aged 18 – 65 years
- Both parents are Japanese
- Weight 45 – 100 kg
- BMI less than 34 kg/m2
- Non-smokers
- Not taking any medications

What is Involved?

SAD Cohorts:

Overnight stay: 1 x 3 night stay
Follow up: 6 follow-up visits
Compensation: $4,000 (less tax)

Important Documents

Important documents to download and read

BRAVO SAD IMPORTANT INFORMATION - ENG

BRAVO SAD IMPORTANT INFORMATION - JP

BRAVO SAD VISIT PLANNER - EXAMPLE

Pre-screening

Personal details

Please provide your name, email and phone number so we can contact you

Name(Required)

Biological sex(Required)

Date of birth(Required)

Email(Required)

Contact Number (within New Zealand)(Required)

Medical questions

Weight (kg)(Required)

Height (cm)(Required)

Do you smoke or vape?(Required)

If yes, please put the vape strength or indicate the average number of cigarettes per day.

List of regular prescription medications:(Required)

List of pre-existing medical conditions:(Required)

Allergic reactions to medicines or foods?(Required)

Visa and/or tax status?(Required)

E.g., resident working visa, student visa, working holiday visa

How long will you be in New Zealand for?(Required)

Are both of your biological parents Japanese?(Required)

Are all four of your grandparents Japanese?(Required)

What region of New Zealand do you live in?(Required)

This will allow us to determine any travel expenses that may be needed on the study

COVID-19 vaccination status?(Required)

Please indicate the number of doses you have received

Is there anything else we should be aware of in term of your medical history?

Visit dates(Required)

Have you looked at the study dates and are okay to come in those days? Indicate which group/s you are available for. This means having flexibility for more than one group increases your chances of being accepted into a group.

Pre-screening form policy(Required)

I understand that by submitting this form, NZCR will use the information for pre-screening purposes for this study. This information may be recorded on your profile to allow us to improve our process when screening you for a future study. All information provided is confidential. I also understand that by submitting this form, I will be receiving emails, texts or calls about this study. For more information, please refer to the Privacy Policy (https://www.nzcr.co.nz/privacy-policy/).

I agree