Die Studie

Die Studie ist in Englisch. Um Teil zu nehmen, müssen Sie der englischen oder holländischen Sprache mächtig sein.

Study of a new compound that is being developed for the treatment of autoimmune diseases such as rheumatism

  • You are a healthy male of healthy no longer fertile female between 18-55 years old.
  • As a female you are only allowed to participate in this study if:
    • you are surgically sterilized before the start of the study;
    • you are postmenopausal for at least 12 months (without menstrual periods).
  • As a male you are only allowed to participate in this study if:
    • you use a condom with your female partner during the study and your fertile female partner uses a form of contraception (e.g. the pill).
    • or your female partner is surgically sterilized;
    • or your female partner is postmenopausal for at least 12 months (without menstrual periods).
    • or you are vasectomized at least 12 months before the start of the study;
    • or you are truly abstinent during the study.
  • Your Body Mass Index (BMI) is between 18.0 and 30 kg/m2 and your body weight is between 50 and 100kg. 
  • You do not smoke or are a occasional smoker. During your stay in the research facility smoking is not allowed.
  • You have not participated in any other drug study within 2 months preceding the first administration of the study compound.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening at our screening centre in Utrecht or Groningen

Zeitraum

For groups 1-6 the study consists of 1 period where you will stay for 5 days (4 nights) in our research facility in Groningen.

For group 7 the study consists of 3 periods where you will stay for 5 days (4 nights) in our research facility in Groningen. The following period will start 7 days after administration of the study compound in the previous period.

For groups 8-11 the study consists of 1 period where you will stay for 18 days (17 nights) in our research facility in Groningen.

For all groups the follow-up will take place 6 days after the last study compound administration for all groups.

Group 18 or 5 days stay
9a 29 Oct - 15 Nov 2019
5b 11 - 15 Nov 2019
5c 19 - 23 Nov 2019
10 21 Nov - 8 Dec 2019
6 8 - 12 Dec 2019

Please note: You have to be available for all dates for the group of choice to be able to participate in this study. The actual dates will be published on our website. These are the currently planned dates; however, these may be subject to change.

Honorar

You will receive a gross compensation of € 745,- for full participation in one of the group 1 – 6.

You will receive a gross compensation of € 1930,- for full participation in group 7.

You will receive a gross compensation of € 2362,- for full participation in one of the group 8 – 11.

Travelling expenses will be reimbursed based on the distance traveled (€ 0,19 net per kilometer) with a minimum of € 12,- and a maximum of € 160,- (840 kilometers) per return, irrespective of the method of transportation.