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PRA-QHLBHQ06-0D1UP1

Autoimmunkrankheiten

  • M/F
  • 18 - 60 years old
  • Non-smoker
  • Healthy

Clinical trial of a new compound that is being developed for the treatment of autoimmune diseases

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Participant ICON

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 60 years old
  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2
  • Non-smoker

Good to know about this trial

  • The study compound is administered via a tablet
  • You contribute to the development of new medicines

Download the complete research overview.

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 study we will investigate how quickly and to what extent the compound is absorbed, transported and eliminated from the body.The study compound is a new compound that may potentially be used for the treatment of autoimmune diseases. An autoimmune disease is a condition where the cells in the immune system attack your own body. This can lead to damage to nerve cells, the study compound may prevent this damage.

WHO CAN PARTICIPATE?

Target group

  • You are a healthy male or female.
  • You are at least 18 and at most 60 years old.
  • Your body mass Index (BMI) is at least 18.0 and at most 30.0 kg/m2
  • You do not smoke and you have not used any nicotine-containing products within 2 months prior to the (first) dosing.

Note:

You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to dosing in the research facility (counting from the last dosing in the previous study).

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 (copper) intra-uterine device);
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • 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 in combination with an additional contraception method used by your fertile female partner (for example the contraceptive pill or intra-uterine device);
  • You have been sterilized 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.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

You will receive a gross compensation of €4708 for participation in group A11 of this trial.

You will receive a gross compensation of €2972 for participation in group FE2 of this trial.

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

Group A11:

The trial consists of 3 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights). After these 3 periods there will be 3 short visits, the follow-up visit will take place during the last visit.

Group FE2:

The trial consists of 2 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 5 days (4 nights). After these 2 periods there will be 3 short visits, the follow-up visit will take place during the last 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 may take part in four studies per year. There must be a period of at least 30 days between each study. A longer waiting time applies for some studies. 

Unfortunately, not all side effects of a drug can be predicted. However, doctors can estimate which side effects will occur based on previous research. During the study, the doctors and nurses carefully monitor participants. 

No. The amount of compensation for participating in a trial is based on the length of the trial. The longer the trial lasts and the more times you need to come back in, the higher the compensation. The compensation is provided to reimburse you for your time as a participant. The Medical Research Ethics Committee (MREC) ensures that the compensation is reasonably proportionate to the time you spend as a participant. 

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