Die Studie
Clinical trial of an investigational compound that is being developed for the treatment of immune system diseases.
- You are a healthy male or female.
- You are minimal 18 and maximal 65 years old.
- Your Body Mass Index (BMI) is minimal 18.0 and maximal 32.0 kg/m2.
- Both non-smokers and light smokers or occasional smokers (up to 5 cigarettes per day) are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.
Note:
- You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the screening in this clinical trial (counting from the follow-up visit). For some study compounds this can be 3 months, this will be discussed during your telephone screening.
- For this trial, you cannot (have) receive(d) a COVID-19 vaccine within 2 weeks prior to the first compound administration until 2 weeks after the last study compound administration.
- To determine if you are suitable to participate in this trial, you will undergo a medical screening.
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
- Your male partner has been surgically sterilized (medically confirmed);
- You are not sexually active according to your lifestyle;
- You are only sexually active with a partner of the same sex.
As a male you can only participate if you meet one of the following conditions;
- You are using a condom during sexual contact with your fertile partner;
- You have been sterilized (medically confirmed) or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
- You are not sexually active according to your lifestyle;
- You are only sexually active with a partner of the same sex.
Zeitraum
Part A: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 4 days (3 nights), followed by 8 short visits. The follow-up visit will take place during your last short visit.
Part B: The trial consists of 4 periods during which each period you will stay in the research facility in Groningen (location van Swietenlaan 6 for 4 days (3 nights). The first 3 periods are followed by one short visit. The last period is followed by 6 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. The current dates of the clinical trial will be published on our website.
Aufwandsentschädigung
- You will receive a gross compensation of € 3036 for participation in one of the groups of part A.
- For participation in one of the groups of part B of the trial, you will receive a gross compensation of € 5819
Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.
Zusätzliche Information
In this trial it will be investigated how safe the investigational compound is and how well it is tolerated when it is used by healthy participants. Also, it will be investigated how quickly and to what extent the investigational compound is absorbed, transported and eliminated from the body. The investigational compound may potentially be used for the treatment of immune system diseases such as: rheumatoid arthritis (inflammation of joints), gout and inflammatory bowel disease.
The trial consists of two parts: part A and part B. In part A you will receive the study compound once. In part B you will receive the study compound 4 times, once during each period of stay.
Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können.