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我们正在寻找中国人参与临床研究
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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

This study is testing the biosimilarity of a single dose of a potential new drug called BP16 (Denosumab). BP16 as a potential new treatment for osteoporosis. Osteoporosis (meaning ‘porous bones’) is a condition which results in a loss of bone mass, weakening bones and leads to greater risk of fractures (broken bones).

BP16 is expected to have the same action and the same range of effects in the body as that of EU-Prolia® or US-Prolia®. Conducting a clinical trial such as this one helps in proving this similarity between the drugs.

This study (2023 FULL 18838) is being funded by ACuraTeQ Biologics Private Ltd and has been approved by the Health and Disability Ethics Committee.

Study Candidates

  • Healthy Males only
    • Age 28 – 55
    • Weigh 60 – 100 kg (inclusive)
    • BMI 18.5 – 30 kg/m2
    • Non-smokers or Ex-smokers
    • Not currently taking any medications

What is Involved?

Study Visits: 3 night inpatient stay

Outpatient visits: 21 follow – up visit

Reimbursement: $7,176 (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 4 weeks or been in isolation?
Have you received any vaccinations in the last 14 days?
Have you previously participated in a study with NZCR or any other organisation? Give details or leave blank if no
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?
For this study you must refrain from smoking (including vape use) for the duration of the study (90 days). Please indicate any use over the past 3 months.
Any recreational drug use within the last 12 months is exclusionary for this study and drug tests are performed on site. Alcohol consumption is also prohibited for the first 2 weeks of the study. Do you have any concerns or are unable to adhere to these restrictions?
Have you had any history of bone fractures? Or any history or current conditions relating to your bones? (e.g., weak/soft bones)
Do you have any history of medical conditions relating to:(Required)
Have you taken any prescription, vitamins, supplements, pharmacy medication or over the counter medications in the last 14 days? Please include any Vaccines in the last 90 days.
Are you able to commit to the study dates for one of the available groups as outlined in the study schedule? Please indicate which group/s you are available or have a preference for. Any flexibility or availability for more than one group will increase your chances of being offered a position on 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/).