PRA-170751 Chronic autoimmune diseases € 2.028,-

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Description

Study of a new compound that is being developed for the treatment of chronic autoimmune diseases like rheumatoid arthritis (RA) or psoriasis

Requested participants

  • Male, healthy, 18 - 45 years old

Duration and visits

  • 7 days stay
  • 7 short visits afterwards

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Research details

Particulars

  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI shows the relation between body weight in
    kilograms and length in meters.
  • Both non-smokers and smokers are allowed to participate in this study; however, during your stay in the research
    facility, smoking is not allowed.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening.
     
Calculate BMI

Compensation

You will receive a gross compensation of € 2.028,- for 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, regardless of the mode of transportation.

Period of stay and research

The study consists of 1 period during which you will stay in our research facility in Groningen, location UMCG for 7 days (6
nights), followed by 7 short visits.

Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the
currently planned dates; however, these may be subject to change.

Information sheet PRA-170751

Type of study

The purpose of the study is to investigate to what extent the study medication is safe and tolerated. It will also be investigated how quickly and to what extent the study medication is absorbed and eliminated from the body. In addition, the effect on specific white
blood cells will be investigated

The study drug is not registered as a drug and has not been given to humans before. The study will only take place after it has been approved by the Independent Ethics Committee.

Setup and duration of the study

The actual study will consist of 1 period during which you will stay in the clinical research center in Groningen, location UMCG for 7 days (6 nights) followed by 7 days during which you will visit the clinical research center in Groningen, location Martini for a short visit.

Before the start of the study you will visit the medical screening centre in Groningen, location Martini. You will receive the study drug and / or placebo once as an injection under the skin of the abdomen (subcutaneous). Blood samples will be taken regularly during the study.

Risks and medical supervision

All potential drugs cause adverse effects; the extent to which this occurs differs. As the new study drug will be administered to man for the first time in this study, adverse effects of man have not been reported to date. However, it has been studied in animals. The most frequently observed adverse effects in animals were: Increased heart rate in a 13-week study in monkeys. The doses these monkeys received were higher than those given in the current study. The increase in heart rate was believed to be due to overreaction of the immune system (see item 3 below for further details) and skin rash.

You will be under strict medical supervision during the study. Before the study and at the end of the study you will undergo an extensive medical screening.

Conditions for participation

You are a healthy male between 18 and 45 years old. You can only take part in the study if you do not smoke or smoke less than 10 cigarettes per day, however during your stay in the research facility, smoking is not allowed. 

The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including products made of chocolate), grapefruit (juice) and tobacco products during the study is not allowed. Also before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine is allowed. Before you are allowed to take part in the study, you will be medically screened; this screening will take place within four weeks before the start of the study.

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Group 6b

€ 2.028,-

7 days stay

  • 16 Jan 2018 up to and including 22 Jan 2018

possible prolongation

  • Inapplicable

checkups

  • 24 Jan 2018
  • 28 Jan 2018
  • 31 Jan 2018
  • 6 Feb 2018
  • 14 Feb 2018
  • 28 Feb 2018
  • 14 Mar 2018

Follow-up

Inapplicable

Group 7a

€ 2.028,-

7 days stay

  • 18 Feb 2018 up to and including 24 Feb 2018

possible prolongation

  • Inapplicable

checkups

  • 26 Feb 2018
  • 2 Mar 2018
  • 5 Mar 2018
  • 11 Mar 2018
  • 19 Mar 2018
  • 2 Apr 2018
  • 16 Apr 2018

Follow-up

Inapplicable

Group 7b

€ 2.028,-

7 days stay

  • 20 Feb 2018 up to and including 26 Feb 2018

possible prolongation

  • Inapplicable

checkups

  • 28 Feb 2018
  • 4 Mar 2018
  • 7 Mar 2018
  • 13 Mar 2018
  • 21 Mar 2018
  • 4 Apr 2018
  • 18 Apr 2018

Follow-up

Inapplicable

Group 4a

€ 2.028,-

7 days stay

  • 29 Oct 2017 up to and including 4 Nov 2017

possible prolongation

  • Inapplicable

checkups

  • 6 Nov 2017
  • 10 Nov 2017
  • 13 Nov 2017
  • 19 Nov 2017
  • 27 Nov 2017
  • 11 Dec 2017
  • 27 Dec 2017

Follow-up

Inapplicable
Group full

Group 4b

€ 2.028,-

7 days stay

  • 31 Oct 2017 up to and including 6 Nov 2017

possible prolongation

  • Inapplicable

checkups

  • 8 Nov 2017
  • 12 Nov 2017
  • 15 Nov 2017
  • 21 Nov 2017
  • 29 Nov 2017
  • 13 Dec 2017
  • 27 Dec 2017

Follow-up

Inapplicable
Group full

Group 5a

€ 2.028,-

7 days stay

  • 3 Dec 2017 up to and including 9 Dec 2017

possible prolongation

  • Inapplicable

checkups

  • 11 Dec 2017
  • 15 Dec 2017
  • 18 Dec 2017
  • 22 Dec 2017
  • 2 Jan 2018
  • 15 Jan 2018
  • 29 Jan 2018

Follow-up

Inapplicable
Group full

Group 5b

€ 2.028,-

7 days stay

  • 5 Dec 2017 up to and including 11 Dec 2017

possible prolongation

  • Inapplicable

checkups

  • 13 Dec 2017
  • 17 Dec 2017
  • 20 Dec 2017
  • 27 Dec 2017
  • 3 Jan 2018
  • 17 Jan 2018
  • 31 Jan 2018

Follow-up

Inapplicable
Group full

Group 6a

€ 2.028,-

7 days stay

  • 14 Jan 2018 up to and including 20 Jan 2018

possible prolongation

  • Inapplicable

checkups

  • 22 Jan 2018
  • 26 Jan 2018
  • 29 Jan 2018
  • 4 Feb 2018
  • 12 Feb 2018
  • 26 Feb 2018
  • 12 Mar 2018

Follow-up

Inapplicable
Group full

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