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SA0085-1349-GRQ

Autoimmune disorders

  • M/F
  • 18 - 45 years old
  • Healthy

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

  • From Juli 2025
  • 12 days

€3030,-

Very positive experience. You are guided step by step through the proces.

Maurice

Participant ICON

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 45 years old
  • You weigh between 40 and 100 kg
  • Your Body Mass Index (BMI) is between 18 and 32 kg/m2

Good to know about this trial

  • The study compound has been administered to humans before in the form of capsules.
  • In this study a new composition of the compound, in the form of tablets, will be tested. The functioning of the different compositions will be compared.
  • You will receive the compound 3 times: once in the form of a tablet after a night of not eating or drinking, once in the form of capsules after a night of not eating or drinking, and once in the form of a tablet after a high-fat breakfast. The order in which you will receive the treatments will be determined by drawing lots.

 

Wie funktioniert es

Wie funktioniert es?

Weiter lesen

Study groups

Register without obligation for the group of your preference

The research physician about this research

Additional information

The study compound could potentially be used for the treatment of autoimmune disorders. The human body is continuously producing new cells. To stay healthy, it is important for the body to also be able to clean up cells.  The death of cells that are no longer needed has to be strictly regulated in the body. However, with autoimmune diseases, something goes wrong when clearing away cell remnants. Too many cells die. The study compound inhibits this to stop the disease from worsening.

The compound has already been extensively tested in the laboratory and in animals, in addition it has been tested in healthy individuals and patients with autoimmune disorders. The compound was well-tolerated. Side effects that were reported most frequently included headaches and drowsiness. You may experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. This information will also be discussed with you at the start of the medical screening. You can then ask questions to the screening physician or nurse. Once everything is clear to you, you can decide to give written consent to participate in the trial. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.

Who can participate?

Target group

  • You are a healthy male or female.
  • You are at least 18 and at most 45 years old.
  • Your Body Mass Index (BMI) is at least 18.0 and at most 32.0 kg/m2, and as a male you weigh at least 50.0 kg and at most 100.0 kg, and as a female you weigh at least 40.0 kg and at most 90.0 kg.
  • Both non-smokers and light smokers or occasional smokers (no more than 5 cigarettes per week) 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 60 days prior to the admission in this clinical trial (counting from the last dosing in the previous trial).
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.
  • 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;
    • 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 female partner;
      • 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 € 3030 for participation in this trial. Travel expenses will be reimbursed based on the distance traveled (€ 0.23 net per kilometer) with a minimum of € 14.23 and a maximum of € 193.20 (840 kilometers) per round trip, regardless of the mode of transportation.

How long does this research take?

Period of stay and research

The trial consists of 3 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 4 days (3 nights). The follow-up visit will take place 5 to 7 days after your final departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial.

Lees meer over het onderzoek

Overige informatie

Informatie uit het A4 onder het kopje 'Over het onderzoek' 

Informatie uit het A4 onder het kopje 'Opzet en duur van het onderzoek' 

Informatie uit het A4 onder het kopje 'Risico's en medische begeleiding' 

Informatie uit het A4 onder het kopje 'Voorwaarden voor deelname' 

Veelgestelde vragen

Je mag maximaal 4 keer per jaar deelnemen aan een onderzoek. Tussen twee onderzoeken moeten minstens 30 dagen zitten. Voor sommige onderzoeken geldt een langere wachttijd.

 

Je kunt tijdens het onderzoek last krijgen van bijwerkingen. Voordat een geneesmiddel op mensen mag worden getest, is het al uitgebreid onderzocht in een laboratorium. Daardoor kunnen we goed voorspellen welke bijwerkingen je eventueel kunt krijgen en kunnen we je daarop voorbereiden. Het komt dus bijna nooit voor dat deelnemers last krijgen van onverwachte bijwerkingen. Een allergische reactie op het middel komt gemiddeld bijvoorbeeld één keer per jaar voor.

Als je meedoet aan geneesmiddelenonderzoek, moet je een paar keer per dag iets doen voor het onderzoek, zoals een test of gezondheidscheck. Maar je hebt ook veel tijd voor jezelf! In het onderzoekscentrum vind je van alles om die tijd mee in te vullen. Er zijn bijvoorbeeld computers, Playstations, tv’s met Netflix, maar ook een tafeltennistafel, pooltafel en een dartbord. En natuurlijk is er wifi, dus neem gerust je eigen laptop of tablet mee. Sommige deelnemers gaan voor hun werk of studie aan de slag. Maar je kunt natuurlijk ook een paar dagen lekker ontspannen.

Hoeveel geld je krijgt voor jouw deelname aan een geneesmiddelenonderzoek, wordt bepaald door de duur van het onderzoek. Hoe langer het onderzoek duurt, hoe hoger de vergoeding. Maar er zijn meer factoren die de hoogte van de vergoeding bepalen, zoals speciale medische handelingen.

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