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PRA-22821X

Erkrankungen des Immunsystems

  • M/F
  • 18 - 65 years old
  • Healthy

Clinical trial of an investigational compound that is being developed for the treatment of immune system diseases

Positive and very friendly and committed employees

Yara

Participant ICON

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 65 years old
  • Your Body Mass Index (BMI) is between 18 and 32 kg/m2

Good to know about this trial

  • The medical screening will take place in Groningen
  • Both non-smokers and light smokers or occasional smokers are allowed to participate
  • You contribute to the development of new medicines

Download the complete research overview of part A.

Wie funktioniert es

Wie funktioniert es?

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Study groups

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THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

In this trial it will be investigated how safe the investigational compound is and how well it is tolerated when it is used by healthy participants. Also, it will be investigated how quickly and to what extent the investigational compound is absorbed, transported and eliminated from the body. The investigational compound may potentially be used for the treatment of immune system diseases such as: rheumatoid arthritis (inflammation of joints), gout and inflammatory bowel disease.

The trial consists of two parts: part A and part B. In part A you will receive the study compound once. In part B you will receive the study compound 4 times, once during each period of stay.

Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können.

WHO CAN PARTICIPATE IN THIS TRIAL?

Target group

  • You are a healthy male or female.
  • You are minimal 18 and maximal 65 years old.
  • Your Body Mass Index (BMI) is minimal 18.0 and maximal 32.0 kg/m2. 
  • Both non-smokers and light smokers or occasional smokers (up to 5 cigarettes per day) are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the screening in this clinical trial (counting from the follow-up visit). For some study compounds this can be 3 months, this will be discussed during your telephone screening.
  • For this trial, you cannot (have) receive(d) a COVID-19 vaccine within 2 weeks prior to the first compound administration until 2 weeks after the last study compound administration.
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. 

As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:

  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
  • You are using a copper intra-uterine device in combination with a condom;
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized
  • Your male partner has been surgically sterilized (medically confirmed);
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

As a male you can only participate if you meet one of the following conditions;

  • You are using a condom during sexual contact with your fertile partner;
  • You have been sterilized (medically confirmed) or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

The compensation for this trial

Compensation

  • You will receive a gross compensation of € 3036 for participation in one of the groups of part A.
  • For participation in one of the groups of part B of the trial, you will receive a gross compensation of € 5819

Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.

HOW LONG DOES THIS RESEARCH TAKE?

Period of stay and research

Part A: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 4 days (3 nights), followed by 8 short visits. The follow-up visit will take place during your last short visit.

Part B: The trial consists of 4 periods during which each period you will stay in the research facility in Groningen (location van Swietenlaan 6 for 4 days (3 nights). The first 3 periods are followed by one short visit. The last period is followed by 6 short visits. The follow-up visit will take place during your last short visit.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.

Frequently asked questions

You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period.

During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous.

Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.

A trial usually involves 5 to 12 participants. The groups are set up so they best match the requirements of the trial. These requirements are described for each trial. View all current trials.

Your participation in a clinical trial is always voluntary. You can therefore decide to stop at any time. Sometimes you have to stop. For example because of family circumstances or if the doctor decides it is better for your health. If you stop, we will look at what portion of the compensation you are entitled to. It's only fair!

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