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我们正在寻找中国人参与临床研究
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AKL & HAM - 0800 788 3437
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 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

Acute alcoholic hepatitis (AH) is a serious acute (sudden) form of alcoholic liver disease. This is caused by the fact that when alcohol is processed in the liver, it produces toxic chemicals that kill the liver cells. Mild to moderate cases resolve without treatment, but severe cases are associated with 15 to 20% death rates at 1 month and 30% at 3 months. There is no approved treatment for this disease.

SZN-043 is a type of medication called an antibody fusion protein. SZN-043 binds only to certain proteins on the surface of liver cells and enhances the signals in the liver telling the liver cells to divide and grow. Increasing the number of liver cells may help overcome the number of liver cells being destroyed by the alcohol resulting in improved liver function and patient outcomes.

This study will investigate the effects of SZN-043 in healthy participants (Part 1) and patients with liver cirrhosis (Part 2). The purposes of Part 1 of this study are to:

• Evaluate how safe SZN-043 is, following multiple doses in patients with liver cirrhosis.

• Evaluate how much and how quickly SZN-043 is absorbed into the blood, and then broken down or eliminated from the body [pharmacokinetics (PK)].

• Evaluate if the body develops antibodies against SZN-043 in patients with liver cirrhosis (ADA).

• Evaluate the effects of SZN-043 on the liver by looking at changes of molecules in your blood, and by looking at how quickly a metabolite leaves your body (“gets excreted”) as measured in your breath.

Study Candidtes

  • Healthy male and females
  • Aged 18 – 50 years
  • BMI 18-32 kg/m2
  • No significant diseases, infections, medical conditions, or allergies
  • Not currently taking any medication
  • No history of drug or alcohol abuse (Including but not limited to cocaine and phencyclidine (PCP)).
  • Smokers allowed

What is Involved?

  • Overnight stay: one 3-night stay, one 1-night stay
  • Follow up: 11 follow-up visits
  • Compensation: $5,000 (less tax)

Important Documents

Important documents to download and read

Please note you need to scroll through the PDF to view each cohort. If these dates don’t suit, there will be more dates coming up.

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 had a fever (more than 38 degrees celsius) or been sick with any bacterial or viral infections in the last 2 weeks?
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 (35 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 bone fractures in the last 4 weeks? Or any history or current conditions relating to your bones? (e.g., weak/soft bones)
Do you have any history of cancer?
Do you have any history of abnormal blood pressure measurements or any history or current heart disease or heart related conditions/abnormalities?
Have you taken any prescription, vitamins, supplements, pharmacy medication or over the counter medications in the last 28 days? Please include any Vaccines in the last 3 months
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.
Each group has 2 periods where you are required to stay at NZCR as part of the study (one 3-night stay and one 1-night stay). Are you available to stay for both check-in dates?(Required)
As part of agreeing to participate in the study, you're required to remain on site at our clinic in Grafton between check-in and check-out as outlined in the schedule. Please let us know if you have any concerns.
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/).