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我们正在寻找中国人参与临床研究
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CHC & WLG - 0800 862 278

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

PRX-115 is being developed for the treatment of severe gout. Gout develops when elevated uric acid levels in the blood forms crystals in the joints, making the joints red, hot and painful. The crystals can also form in urine as it is filtered through the kidneys, causing kidney stones. Uric acid itself is a natural substance found in the blood of all mammals and is a by-product of how our bodies process dietary protein into energy.

PRX-115 is an artificially created version of uricase, an enzyme that is found in most mammals (except humans) that breaks down uric acid. Mammals with uricase don’t get gout. Unfortunately, the human gene that makes uricase has mutations that stop us from making the enzyme at all. As a result, our blood contains 3 to 10 times more uric acid than that of other mammals, which is why humans can develop gout and other mammals do not.

It is hoped that PRX-115 will break down uric acid in the blood and may be an effective treatment for people with gout.

The purpose of this study is to:
• Evaluate how safe and well tolerated intravenously (IV) administered PRX-115 is, in participants with elevated uric acid levels.
• Measure levels of PRX-115 in the blood over time, following a single IV dose.
• Measure the body’s response to a single dose of IV administered PRX-115.
• Assess the body’s immune response to PRX-115.

This study (2022 FULL 13676) is being funded by Protalix and has been approved by the Health and Disability Ethics Committee.

Study Candidates

  • Males and females
  • Aged 18 – 65 years
  • BMI 18.5 – 40 kg/m2
  • Smokers allowed
  • Any medication will be recorded and reviewed

What is Involved?

Study Visits: 3 nights + 9 visits visits

Reimbursement: $4,200 (less tax)

Important Documents

Important documents to download and read

Pre-screening Form

Personal details

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

Medical questions

Have you had any covid symptoms in the last two weeks or been in isolation?
This study requires the use of contraception during the study. If you are in a hetereosexual relationship both partners must agree to use contraception (condoms for males | IUD, birth control or another approved form for females). Are you currently using 2 forms of contraception?
Have you previously participated in a study with NZCR or any other organisation? Give details or leave blank if no
Have you donated blood or plasma in the last few months? If yes please provide details
Any history or current autoimmune disorders? Are you being treated with any immunosuppressive medication? - For e.g., psoriasis, rheumatoid arthritis, Crohn’s disease, or ulcerative colitis etc
Do you have any conditions known to have arthritis as a clinical manifestation? e.g. (rheumatoid arthritis, psoriatic arthritis, ankylosing and non-radiographic spondylitis, reactive arthritis, psoriasis, chondrocalcinosis, or pyrophosphate arthritis)
Do you have any history of being anemic or low in iron? (G6PD deficiency) or other blood related disorders
Do you have any history of high or low blood pressure? If yes please provide details
Do you have any history of clinically significant acute systemic infection and/or antibiotic treatment within 28 days?
Have you had any chronic infections that was symptomatic in the last 3 months? Include localised infections, coughs, fever etc. Herpes UTIs ringworm, conjunctivitis, styes, warts, etc (Not including fungal foot infection).
Do you have any history of medical conditions relating to:(Required)
If you have none, please select the last option.
If unsure please note down what vaccines you have had in the last 3 months and when.
Do you have any history of allergies, asthma, hay fever, food allergies etc that you are aware of?
Have you taken any prescription, vitamins, supplements, pharmacy medication or over the counter medications in the last 28 days?
Have you looked at the study dates and are okay to come in those days? Indicate which group/s you are available for. Flexibility for other groups increases your chances of getting into the study.
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/).