The trial

Study of a new compound that is being developed for the treatment of diseases of the immune system.

  • You are a healthy male or female.
  • You are between 18 and 64 years old.
  • You do not smoke.
  • Your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2.

As a male, you can only participate in this study if until 90 days after receiving the last trial medication, you:

  • use a condom, or
  • remain abstinent from sexual intercourse, if in accordance with your usual lifestyle.

As a female, you can only participate in this study if you:

  • are postmenopausal (no menstrual cycle for at least 12 months), or
  • have been sterilized at least 6 months before the start of the study. 


    Note:

  • For this trial, you cannot (have) receive(d) a COVID-19 vaccine within 13 days prior to the start of each period of the trial and during your stay in the research facility.
  • You can only participate in this study if you have not participated in another study for at least 60 days prior to the first drug administration in this study.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. Based on the availability, this can be done in Groningen or Utrecht.

 

Period

For the C-groups, the study consists of 2 periods, during which you will stay in our research facility in Groningen for 5 days (4 nights) for each period. After the 2nd period a follow-up visit will take place, 2 to 6 days after your discharge from the research facility. This follow-up is a visit to the research facility of a couple of hours. The appointment for your follow-up visit will be made during your stay. 

Group C  
stay  
  • 1 Dec 2021 up to and including 5 Dec 2021
  • 9 Dec 2021 up to and including 13 Dec 2021
 
follow-up  
  • by appointment 15 Dec 2021 up to and including 19 Dec 2021
 

NOTE: You must be available for all specified dates to be able to participate in this study. The current dates of the study are available on our website. These are the currently planned dates; however, these may be subject to change.

Compensation

  • You will receive a gross compensation of €1852 for your participation in part C 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.