• In this trial we will investigate how safe the new study compound is and how well it is tolerated when given to healthy participants.
• The trial consists of 2 parts: part A and part B. You can participate in one part of the trial.
• The study compound can potentially be used for the treatment inflammatory disease conditions and autoimmune disorders. Inflammatory disease conditions and autoimmune disorders are medical conditions where the body's immune system mistakenly attacks its own tissues, leading to chronic inflammation and damage.
• During the study, your heart will be continuously monitored for 24 hours, starting 90 minutes before (each) administration. For this, stickers (electrodes) will be attached to your chest and connected to a small device. At various times, you will need to lie still for 15 minutes without moving, talking, or sleeping. During these periods, you will also not be allowed to listen to music, watch TV, or use a laptop or phone. However, outside of these moments, you are allowed to do this.
• All (potential) medicines can cause side effects. Because the compound has not yet been administered to humans, there are currently no known side effects in humans. In rare cases (<0.1%), serious side effects can occur during the first administration to humans. The compound has already been extensively tested in the laboratory and on animals. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects based on these animal tests. This information will also be discussed with you at the start of the medical screening. You can then ask questions to the screening physician or nurse. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.

• You are a healthy male or female.
• You are between 18 and 65 years old.
• Your weight is at least 50 kg and no more than 120 kg and your Body Mass Index (BMI) is at least 18.0 and at most 30.5 kg/m2. 
• Only non-smokers (not having smoked for 3 months prior to screening) are allowed to participate in this clinical trial.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 12 weeks prior to medical screening in this clinical trial (counting from the last compound administration).
• To determine if you are suitable to participate in this trial, you will undergo a medical screening including physical exam and laboratory tests. 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 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 with your female partner;
    • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
    • You are not sexually active from the medical screening until 63 days after the last compound administration;
    • You are only sexually active with a partner of the same sex.

Part B of the trial consists of 2 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 17 days (16 nights) during the first period. The second period of stay will be 9 days (8 nights). The second period of stay in the clinic will be followed by 5 short visits. The follow-up visit will take place during your last short visit.  

Note: You must be available for all dates to be able to participate in this clinical trial.