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PRA-CHMBGJ99-0D1SBM

Psoriasis

  • M
  • 18 - 55 years old
  • Healthy

Arzneimittelstudien zu einem neuen Wirkstoff, der für die Behandlung von Autoimmunkrankheiten entwickelt wird, zum Beispiel Psoriasis. 

Everything was arranged well and professionally.

Noah

Participant ICON

Find out if you qualify for this trial

  • You are a healthy male
  • You are between 18 and 55 years old
  • You weigh between 60 and 100 kg
  • Your Body Mass Index (BMI) is between 18.5 and 29.9 kg/m2

Good to know about this trial

  • The medication will be administered twice
  • The compound is compared with a similar existing drug
  • After the second period you will receive half of the compensation
  • A short visit lasts a maximum of one hour and your travel costs will be reimbursed
  • The short visits can also take place in Utrecht

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

An auto-immune disease is a condition in which the immune system turns against its own body. Examples of autoimmune diseases include arthritis and psoriasis.

The purpose of this trial is to investigate how quickly and to what extent the newly developed compound is absorbed, broken down, and eliminated by the body. This is compared to a similar compound that is already available on the market. For the similar compound, there is both a US-marketed and an EU-marketed product. The trial consists of two periods. You will randomly be assigned to receive 2 compounds in a random order (1 compound per period). The options are:

  1. New compound versus an EU-marketed compound.
  2. New compound versus a US-marketed compound.
  3. EU-marketed compound versus a US-market compound.

The compounds will be administered as a subcutaneous (under the skin) injection in the abdomen.

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.
  • You are at least 18 and at most 55 years old.
  • Your weight is at least 60 kg and at most 100 kg and your Body Mass Index (BMI) is at least 18.5 and at most 29.9 kg/m2. 
  • Both non-smokers and light or occasional smokers are allowed to participate (at most 5 cigarettes per day). During your stay in the research facility, smoking is not permitted.

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the follow-up visit).
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening.

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;
  • 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.

WHO CAN PARTICIPATE?

Compensation

You will receive a gross compensation of € 5853 for participation if you complete the 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

The trial consists of 2 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 9 days (8 nights). Each period is followed by 4 short visits. The follow-up visit will take place during the final 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.

Current trials

Participate in another study?

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View all clinical trials