Study of a new investigational compound for the treatment of a autoimmune disease
- You are between 18 and 55 years old
- Your weight is between 50 kg and 110 kg and your Body Mass Index (BMI) is between 18.5 and 30.0 kg/m2. The BMI reflects the relation between your body weight in kilograms and your height in meters.
- Both non smokers and light smokers can participate, but smoking is not allowed during your stay in the clinical center.
- As a male you are only allowed to participate in this study if:
- You use a condom with your female or male partner;
- your female partner is advised to use an hormonal contraceptive (e.g. the pill) or intrauterine device;
- or you are vasectomized at least 6 months before the start of the study;
- or you are true abstinent during the study.
- As a female you are only allowed to participate in this study if:
- you use a intrauterine device or hormonal contraceptives (e.g. the pill) and your male partner uses a condom;
- or you are true abstinent during the study;
- or you are surgically sterilized at least 6 months before the start of the study;
- or your male partner has been vasectomized at least 6 months before the start of the study;
- or you are postmenopausal for at least 12 months (without menstrual periods).
- Women who are breastfeeding or pregnant can not participate.
- To determine if you are eligible to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 1.300,- for full participation in one of the groups of this 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 return, irrespective of the method of transportation.
Period of stay and research
For each group the study consists of 1 period during which you will stay in our research facility in Groningen for 6 days (5 nights), followed by 4 short visits. In between you have 3 times contact by phone.
The follow up will be during the last short visit.
Please note: You have to be available for all dates to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.
Have you participated in a medical trial before? Then be aware that there needs to be a period of 60 days between the last dosing in the previous study and the dosing in this study.
The medical screening for this study will take place in the screening center in Groningen or Utrecht.
6 days stay
- 19 May 2019 up to and including 24 May 2019
- 27 May 2019
- 3 Jun 2019
- 10 Jun 2019
- 17 Jun 2019
6 days stay
- 28 Mar 2019 up to and including 2 Apr 2019
- 5 Apr 2019
- 12 Apr 2019
- 19 Apr 2019
- 26 Apr 2019
6 days stay
- 2 May 2019 up to and including 7 May 2019
- 10 May 2019
- 17 May 2019
- 24 May 2019
- 31 May 2019