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Inflammotory diseases

Ort der Studie

Study of a new compound that is being developed for the treatment chronic inflammatory diseases (such as rheumatoid arthritis)

 

Besonderheiten (auf Englisch)

  • You are a healthy male or female. 
  • You are between 18 and 55 years old.
  • You do not smoke.
  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2.
  • You can only participate in this study if you have not participated in another study within 12 weeks prior to the first drug administration in this study.
  • As a male you are only allowed to participate in this study if:
    • You will use a condom and your fertile female partner uses an intrauterine device (including copper ones) or a hormonal contraceptive;
    • or you were vasectomized;
    • or your female partner is at least 12 months postmenopausal (without menstrual periods) or surgically sterilized;
    • or you are completely abstinent (not sexually active) during the study in accordance with your lifestyle;
    • or you are only sexual active with a male.
  • As a female you are only allowed to participate in this study if:
    • You have been postmenopausal and you have not menstruated for a period of 12 months before screening
    • You were surgical sterilized (both ovaries or fallopian tubes have been removed, or removal of the uterus)
  • To determine if you are eligible to participate in this study, you will undergo a medical screening in  Groningen. This will take place within 6 weeks before the clinical start.

 

Vergütung (auf Englisch)

You will receive a gross compensation of €2.289,- for full participation in Group 2a or 2b..

Travel 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, irrespective of the method of transportation.

 

Periode und Studie (auf Englisch)

For Group 2a and 2b, the study consists of 1 period in which you will stay in our research facility in Groningen for 14 days (13 nights).

Approximately 12 to 16 days after the last administration of the compound, a follow-up visit will take place.

Please note: These are the currently planned dates; however, these may be subject to change.

 

Group 2a

14 days stay

26 Oct 2020 up to and including 8 Nov 2020

follow-up

by appointment

Group 2b

14 days stay

7 Nov 2020 up to and including 20 Nov 2020

follow-up

by appointment

Group 2c

14 days stay

11 Nov 2020 up to and including 24 Nov 2020

follow-up

by appointment

Groep 2d

 

14 days stay

8 Dec 2020 up to and including 21 Dec 2020

 

follow-up

by appointment

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