• The new study compound is being developed to treat long-term inflammation. This happens when the immune system stays active for a long time. Short-term activity helps fight diseases, but if it lasts too long, it can become harmful. Long-term inflammation is seen in the brain in Alzheimer's disease, Parkinson’s disease and in obesity (severe overweight), as well as in other conditions. Alzheimer's disease is a brain disorder that slowly causes memory loss, confusion, and changes in behavior. Parkinson's disease is a nervous system disorder that causes shaking, stiffness, and difficulty with movement.
• In this clinical trial, we will investigate how the study compound is processed and eliminated by the body and how well it is tolerated when administered to healthy participants. We will also investigate the effect of the compound on the immune system. The effects of the study compound will be compared to the effects of a placebo (drug with no active ingredient).
• The study compound or placebo will be administered as a capsule (by mouth).
• The trial consists of 2 parts: part A and part B. Each part has several groups.
• In part C, you will receive the study compound or placebo once daily for 28 days.  
• Part C: For this part of the study, we are looking for participants with an elevated hCRP level. hCRP is measured in the blood and may be elevated when there is inflammation in the body. To assess whether you may be eligible to participate in this part of the study, your hCRP level may be measured before or during the medical screening. Please contact us for more information.
• Part C: For all groups, 1 additional short visit may take place at the research center for drawing blood. Based on the results of the earlier groups, it may be decided that this short visit will not take place.
• For all groups: 2 additional visits may take place at the research center for drawing blood. Based on the results of the earlier groups, it may be decided that these short visits will not take place.

All (possible) 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 will then have the opportunity to ask the screening physician or nurse any questions. 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 at least 18 and at most 75 years old.
• Your Body Mass Index (BMI) is at least 25.0 and at most 42.0 kg/m²or it is between 18.0 kg/m² and 42.0 kg/m² if you have a diagnosis of type 2 diabetes 
• You do not smoke and do not use any nicotine-containing products.
• As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
  • You are using a copper intra-uterine device in combination with a condom;
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You are only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.
• As a male you can only participate if you meet one of the following conditions:
  • You are using a condom in combination with an additional contraception method used by your female partner, and you are prepared to continue this dual contraception for up to 3 months after the last dose of the study compound;
  • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 3 months prior to the first compound administration in this clinical trial (counting from the follow-up visit). For some trials, this period could be longer. Please contact us for more information to see if this applies to you.
• 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 groups part C: the trial consists of 2 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6). In period 1 you will stay for 3 days (2 nights), in period 2 you will stay for 2 days (1 night). Between period 1 and 2 there will be a 25-day period during which you will take the study medication at home. During these 25 days there will also be 2 short visits to the clinic. After period 2, there will be two additional short visits. Based on the results of previous groups it may be decided that the second short visit will not take place. A last follow-up visit will take place 21-24 days after your departure from the research facility at the end of period 2.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website. You may choose which group you want to participate in, based on your availability.