Die Studie

Clinical trial of a new compound that has been developed for the treatment of autoimmune and inflammatory diseases.

  • You are a healthy male or female
  • You are between 18 and 60 years old
  • Your weight is between 50 kg (part 1) or 61.5 kg (part 2) and 110 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2
  • You do not smoke or you are a light smoker and are able to refrain from smoking and the use of tobacco or nicotine-containing products during your stay in the research facility.

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 3 months prior to this clinical trial (counting from the last dosing).
  • For this trial, you must not have received a COVID-19 vaccine within 14 days prior to the start of the trial up to and including the follow-up.
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

As a female you can only participate if you meet one of the following conditions:

  • You use (hormonal) contraception and your male partner uses a condom;
  • You are sterilized (at least 6 months ago);
  • You are post-menopausal (at least 12 months no menstruation);
  • Your partner is sterilized (at least 6 months ago);
  • You are practicing true abstinence (not sexually active) in accordance with your lifestyle.
  • Females who are breastfeeding or pregnant cannot participate.

As a male you can only participate if you meet one of the following conditions:

  • You use a condom and your fertile female partner uses (hormonal) contraception;
  • You are sterilized (at least 6 months ago) and you use condom;
  • You use a condom and your female partner is sterilized or postmenopausal;
  • You are practicing true abstinence (not sexually active) in accordance with your lifestyle.

Zeitraum

Part 1: For the groups of part 1 the study consist of 4 periods. In the 1st period you will stay in our research facility in Groningen for 6 days (5 nights). After the 1st period there will be 4 short visits. In the 2nd period you will stay for 2 days (1 night) in the research facility. In the 3rd period you will stay for 6 days (5 night) in the research facility. After the 3rd period there will be 2 short visits. In the 4th period you will stay for 2 days (1 night) in the research facility. After the last period of stay there will be 4 short visits. The follow-up visit will take place during the last visit, this appointment will be planned during your stay.

Part 2: The trial consists for group 2a and 2b of part 2 of 1 period during which you will stay in the research facility in Groningen for 9 days (8 nights). After this there will be 6 short visits. The follow-up visit will take place during the last visit, this visit will be planned during your stay.   

The trial consists for group 2c and 2d of part 2 of 1 period during which you will stay in the research facility in Groningen for 16 days (15 nights). After this there will be 6 short visits. The follow-up visit will take place during the last visit, this appointment will be planned during your stay.

Note: You must be available for all dates to be able to participate in this trial. These are the currently planned dates; however, these may be subject to change.

 

Group 1b  
stay  
  • 4 Oct 2021 up to and including 9 Oct 2021
  • 1 Nov 2021 up to and including 2 Nov 2021
  • 15 Nov 2021 up to and including 20 Nov 2021
  • 29 Nov 2021 up to and including 30 Nov 2021
 
short visit  
  • 12 Oct 2021
  • 15 Oct 2021
  • 19 Oct 2021
  • 26 Oct 2021
  • 23 Nov 2021
  • 26 Nov 2021
  • 7 Dec 2021
  • 13 Dec 2021
  • 27 Dec 2021
 
note  Follow up on appointment between January 7 and 13, 2022
Group 2a  
stay 11 Oct 2021 up to and including 19 Oct 2021
short visit  
  • 22 Oct 2021
  • 26 Oct 2021
  • 2 Nov 2021
  • 9 Nov 2021
  • 16 Nov 2021
 
note  Follow up on appointment between November 20 and 26, 2021
Group 2b  
stay 20 Oct 2021 up to and including 28 Oct 2021
short visit  
  • 30 Oct 2021
  • 3 Nov 2021
  • 10 Nov 2021
  • 17 Nov 2021
  • 24 Nov 2021
 
note  Follow up on appointment between November 28 and December 4, 2021

Aufwandsentschädigung

  • You will receive a gross compensation of €4421 for participation in group 1a or 1b of part 1 of this study.
  • You will receive a gross compensation of €2339 for participation in group 2a or 2b of part 2 of this study.
  • You will receive a gross compensation of €3221 for participation in group 2c or 2d of part 2 of this study.

Travel 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 round trip, regardless of the mode of transportation.