The trial

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

  • 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.

Note: 

  • For this trial, you cannot (have) receive(d) a COVID-19 vaccine within 13 days prior to the start of the trial and until 28 days after the last administration.
  • You cannot participate in the trial if you have participated in another clinical trial in the 60 days prior to the first administration in this clinical trial (counting from the follow-up visit).
  • 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.
  • For participation in part 3 (not on the website yet): you have an allergy/hypersensitivity to a certain type of food (such as milk or peanuts) or you have an environmental allergy (such as hay fever, high sensitivity to dust, animals, etc.).
    • Food allergy complaints: sudden itch, swelling, wheezing, stomach/intestine complaints, dizziness when standing up.
    • Environmental allergy complaints: sneezing, stuffy nose, itchy nose, runny nose.

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

  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized.

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

  • You are using a condom during intercourse.

Period

For part 1, the trial consists of 2 periods, each of which you will stay in the research facility in Groningen for 5 days (4 nights). The follow-up visit will take place 2 – 6 days after your departure from the research facility after period 2.

Group A  

2× 5 days stay

 
  • 27 Dec 2021 up to and including 31 Dec 2021
  • 6 Jan 2022 up to and including 10 Jan 2022
 
note Follow-up on appointment between Janauary 12 and 16, 2022

Compensation

  • You will receive a gross compensation of € 1714 for participation in one of the groups of part 1.

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.