Autoimmun- und Entzündungskrankheiten

Autoimmun- und Entzündungskrankheiten

Clinical trial of a new compound that is being developed for the treatment of autoimmune and inflammatory diseases

The research physician about this research

In this study the safety and tolerability of the study compound is investigated when administered to healthy volunteers. We also investigate how quickly and to what extent the study compound is absorbed, transported, and eliminated by the body.

Important information about this study

• Halfway through the study, you will already receive half of the compensation
• The study compound will be administered once during the study, this will be on the day after entry in the research facility.
• Between connecting short visits, it is possible to stay overnight in a hotel.

Who can participate?

• You are a healthy male or female between 18 and 55 years old
• Your body weight is between 50 and 110 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2.
• Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial. However, smoking is not allowed during your stay in the research facility.

Note: 

• You cannot participate in the trial if you have participated in another clinical trial in the 60 days prior to this clinical trial (counting from the last study compound administration). This period can also be 90 days for certain trials, please contact us for more information.
• 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.

As a female you can only participate if you are not pregnant and not breastfeeding 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 period for at least 12 months):
• You have been sterilized or your male partner has been sterilized;
• You only have sexual contact with females;
• You are not sexually active.

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 are using a condom and your female partner is sterilized or postmenopausal;
• You are sterilized and you use a condom;
• You are using a condom with your male partner;
• You are not sexually active.

Compensation

You will receive a gross compensation of € 3860 for participation in one of the groups of the study.

Travelling 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.

Period of stay and research

The trial consists of 1 period during which you will stay in the research facility in Groningen for 9 days (8 nights), followed by 8 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 study. The current dates of the study will be published on our website. These are the currently planned dates; however, these may be subject to change.