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Autoimmune diseases

Geschlecht Beides

Alter von 18 bis 54

Gewicht von 50 bis 100

Rauchgewohnheiten Nicht

BMI von 18 bis 30

Berechnen Sie Ihren BMI hier

Ort der Studie

 

Study of a new compound that is being developed for the treatment of autoimmune diseases related to the complement system

 

Besonderheiten (auf Englisch)

  • You are a healthy male or female, between 18 - 54 years old and are living in The Netherlands, Belgium or Germany.
  • Your weight is at least 50-100 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2
  • Only non-smokers can participate in this study.
  • You have not participated in any other drug study within 90 days preceding the first administration of the study compound (counting from the last day in the previous study).
  • As a male you are only allowed to participate in this study if:
    • your female partner uses a hormonal contraceptive or intrauterine device in combination with a condom;
    • or you have been vasectomized at least 6 months before the start of the study;
    • or your female partner is postmenopausal (at least 12 months no menstruation) or has been surgically sterilized (at least 6 months);
    • or you are only sexually active with a male.
    • or you are true abstinent (not sexually active) in accordance with your lifestyle;
  • As a female you are only allowed to participate in this study if:
    • or you have been postmenopausal for at least 12 months.
    • or you have been surgically sterilized at least 6 months before the start of the study;
  • Women who are breastfeeding or pregnant cannot participate.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.

Vergütung (auf Englisch)

You will receive a gross compensation of € 3292 for full participation in part A. You will receive a gross compensation of € 5720 for full participation in part B group 1, 2 and 3. For group 4 of Part B, you will receive a gross compensation of € 6233 for full participation.

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, irrespective of the method of transportation.

 

Periode und Studie (auf Englisch)

The study consists of 2 parts: part A and part B. The groups of part A consists of 1 period in which you will stay for 10 days (9 nights) in our research facility in Groningen. This will be followed by 7 short visits to the research facility.
For part B, group  1, 2 and 3 consists of 2 periods where you will stay for 17 days (16 nights) in the first period and for 10 days (9 nights) in the second period in our research facility in Groningen. This will be followed by 8 short visits to the research facility. Group 4 consists of 3 periods of stay in which you will stay for 10 days (9 nights) each period in our research facility in Groningen. This will be followed by 8 short visits to the research facility.

You can find the exact dates of each group on our website www.praclinicaltrials.com. If the dates do change you will be notified as soon as possible.

 

Group A2c

10 days stay

31 Aug 2020 up to and including 9 Sep 2020

short visit

16 Sep 2020

23 Sep 2020

30 Sep 2020

7 Oct 2020

21 Oct 2020

4 Nov 2020

follow-up

2 Dec 2020

Group A2d

 

10 days stay

2 Sep 2020 up to and including 11 Sep 2020

 

short visit

18 Sep 2020

25 Sep 2020

2 Oct 2020

9 Oct 2020

23 Oct 2020

6 Nov 2020

 

follow-up

4 Dec 2020

Group A3a

 

10 days stay

28 Sep 2020 up to and including 7 Oct 2020

 

short visit

14 Oct 2020

21 Oct 2020

28 Oct 2020

4 Nov 2020

18 Nov 2020

2 Dec 2020

 

follow-up

30 Dec 2020

 

Groep A3b

 

10 days stay

30 Sep 2020 up to and including 9 Oct 2020

 

short visit

16 Oct 2020

23 Oct 2020

30 Oct 2020

6 Nov 2020

20 Nov 2020

4 Dec 2020

 

follow-up

30 Dec 2020

 

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