PRA-166331 Treatment of inflammation processes € 1.448,-

Full

Description

Study of a new compound that is being developed for the treatment of inflammation processes which are enhanced by a specific protein such as asthma and allergies

Requested participants

  • Male, healthy, 18 - 55 years old
  • Non-smokers only

Duration and visits

  • 4 days stay
  • 4 short visits afterwards

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Research details

Particulars

  • You do not smoke
  • Your body weight must be between 60 kg and 100 kg. 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.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening.
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Compensation

You will receive a gross compensation of € 1.448,- 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

For all the mentioned groups underneath the study consists of 1 period were you will stay in our research facility
in Groningen (location Martini) for 4 days (3 nights). After your stay in our research facility there will be 4 short
visits.

Please note: You have to be available for all dates for the group of choice to be able

Information sheet PRA-166331

Type of study

The purpose of the study is to investigate the safety and tolerability of the study medication and how quickly and to what
extent the study medication is absorbed and eliminated in the body (this is called pharmacokinetics [PK]). This study is not intended to improve your health, but is necessary for the further development of the study medication.

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 one period in which you will receive the study medication once administered as a 1 hour infusion. During the study you will stay in our clinical research centre in Groningen (location Martini) for 4 days (3 nights). After your stay in our research facility there will be 4 short visits.

Before the start of the study you will visit the medical screening centre in Groningen (location Martini). Blood samples will be taken regularly during the study.

Risks and medical supervision

All drugs have the potential to cause adverse events. You should be aware that the mentioned adverse effects underneath and possibly other, still unknown adverse effects, may occur during the study.

The study medication is not registered as a drug and has not been given to humans before. The study medication is investigated in animals at dose levels up to 100 mg/kg. This high dose was well tolerated and there was no evidence of harmful effects. The study medication acts by inhibiting inflammation. It is expected that side effects that may occur has something to do with the suppression of the immune system, such as an increased likelihood of infections.

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 55 years old. You can only take part in the study if you do not smoke.
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 5a

€ 1.448,-

4 days stay

  • 2 Oct 2017 up to and including 5 Oct 2017

possible prolongation

  • Inapplicable

checkups

  • 10 Oct 2017
  • 17 Oct 2017
  • 31 Oct 2017
  • 28 Nov 2017

Follow-up

Inapplicable
Group full

Group 5b

€ 1.448,-

4 days stay

  • 3 Oct 2017 up to and including 6 Oct 2017

possible prolongation

  • Inapplicable

checkups

  • 11 Oct 2017
  • 18 Oct 2017
  • 1 Nov 2017
  • 29 Nov 2017

Follow-up

Inapplicable
Group full

Group 6a

€ 1.448,-

4 days stay

  • 30 Oct 2017 up to and including 2 Nov 2017

possible prolongation

  • Inapplicable

checkups

  • 7 Nov 2017
  • 14 Nov 2017
  • 28 Nov 2017
  • 27 Dec 2017

Follow-up

Inapplicable
Group full

Group 6b

€ 1.448,-

4 days stay

  • 31 Oct 2017 up to and including 3 Nov 2017

possible prolongation

  • Inapplicable

checkups

  • 8 Nov 2017
  • 15 Nov 2017
  • 29 Nov 2017
  • 27 Dec 2017

Follow-up

Inapplicable
Group full

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