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 could be used for the treatment of MS (Multiple Sclerosis).

  • We are looking for healthy males and females between 18 and 54 years old.
  • Your bodyweight is between 50 kg and 92 kg and your Body Mass Index (BMI) is between 18.5 and 30.0 kg/m2. The BMI reflects the relationship between your body weight in kilograms and your height in meters.
  • Both smokers and non-smokers can participate, although smoking or use of other nicotine containing products(e.g. nicotine gum) is not allowed during your stay in the clinic.
  • As a male you are only allowed to participate in this study if:
    • your fertile female partner uses an intrauterine device or hormonal contraceptive (e.g. the pill) and you use 1 of the following forms of contraception: a condom, diaphragm or cervical cap;
    • or your female partner is postmenopausal (without menstrual periods);
    • or you are totally abstinent (not sexually active) as a result of your lifestyle.
  • As a female you are only allowed to participate in this study if:
    • you use an intrauterine device or hormonal contraceptives (e.g. the pill) combined with 1 of the following forms of contraception: a condom, diaphragm or cervical cap or you are using this from screening;
    • or you have been postmenopausal for at least 12 months (without menstrual periods);
    • or if you have been surgically sterilized for at least 6 months before the start of the study;
    • or you are totally abstinent (not sexually active) as a result of your lifestyle.
  • You have not participated in any other drug study within 30 days preceding the first administration of the study compound.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. The medical screening for this study will consist of two visits. During the first screening visit we will take a blood- and urine sample to evaluate the presence of the John Cunningham Virus (JCV). If it turns out that you are not a carrier of this virus, the remainder of the medical screening will be conducted during the second visit.

Zeitraum

For each group the study consists of 1 period where you will stay for 10 days (9 nights) in our research center in Groningen. After this period there will be 10 short visits to our research center. Between your departure from our research center and the 1st short visit you will remain at home in self-quarantine.

Group stay short visit follow-up
44 18 - 27 Okt 2020  
  • 3 Nov 2020
  • 10 Nov 2020
  • 17 Nov 2020
  • 24 Nov 2020
  • 1 Dez 2020
  • 15 Dez 2020
  • 29 Dez 2020
  • 5 Jan 2021
  • 12 Jan 2021
  • 20 Apr 2021
 
20 Apr 2021
45 22 - 31 Okt 2020  
  • 7 Nov 2020
  • 14 Nov 2020
  • 21 Nov 2020
  • 28 Nov 2020
  • 5 Dez 2020
  • 19 Dez 2020
  • 2 Jan 2021
  • 9 Jan 2021
  • 16 Jan 2021
  • 24 Apr 2021
 
24 Apr 2021
46 25 Okt t/m 3 Nov 2020  
  • 10 Nov 2020
  • 17 Nov 2020
  • 24 Nov 2020
  • 1 Dez 2020
  • 8 Dez 2020
  • 22 Dez 2020
  • 5 Jan 2021
  • 12 Jan 2021
  • 19 Jan 2021
  • 27 Apr 2021
 
27 Apr 2021
47 27 Okt - 5 Nov 2020  
  • 12 Nov 2020
  • 19 Nov 2020
  • 26 Nov 2020
  • 3 Dez 2020
  • 10 Dez 2020
  • 24 Dez 2020
  • 7 Jan 2021
  • 14 Jan 2021
  • 21 Jan 2021
  • 29 Apr 2021
 
29 Apr 2021

Please note: You have to be available for all dates of the group of your choice to be able to participate in this study. Please see our website for the currently planned dates.

Aufwandsentschädigung

You will receive a gross compensation of € 5250,- for full participation in one of the groups. 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 transport.