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PRA-USCBGW26-0D1T9C

Muscle disease

  • M/F
  • 18 - 55 years old
  • Non-smoker
  • Healthy

Clinical trial of a new compound that is being developed for the treatment of muscle disease

  • From September 2024
  • 6 days
  • 14 visits

€4795,-

Friendly staff, nice fellow participants and decent food!

Liam

Participant ICON

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 55 years old
  • Your Body Mass Index (BMI) is between 18.5 and 30 kg/m2
  • Non-smoker

Good to know about this trial

  • The stays and short visits on September 11 and October 24 will take place in Groningen 
  • The other short visits can take place both in Groningen and in Utrecht
  • The research drug has been administered to humans before

 

How does it work

How does it work?

Read more

Study groups

Register without obligation for the group of your preference

THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

  • In this clinical trial, two different injection methods will be investigated for an approved compound that is already available on the market (Zilucoplan). Furthermore, we investigate how the study compound is processed and eliminated by the body and how well it is tolerated when it is used by healthy participants.
  • There are 2 periods in this trial. You receive a single dose of the study compound in each of the 2 periods, as an injection under the skin of the abdomen.
  • You may need to receive a vaccination against meningococcal disease during the first screening visit based on your previous vaccination history. Furthermore, we will check if you are currently infected with the bacteria that causes meningococcal disease. This will be tested by taking samples from your throat and nose by using swabs. Please contact us if you need more information regarding the vaccination and samples.

WHO CAN PARTICIPATE?

Target group

  • You are a healthy male or female.
  • You are at least 18 and at most 55 years old.
  • Your Body Mass Index (BMI) is at least 18.5 and at most 30.0 kg/m2. 
  • You do not smoke and do not use any nicotine-containing products.

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);
  • 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 with 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.

Note: 
You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the screening of 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. Depending on availability, this can be performed in Groningen or in Utrecht.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

You will receive a gross compensation of € 4795 for participation in the study.

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 which you will stay in the research facility in Groningen (location van Swietenlaan 6). Both periods consist of 3 days (2 nights). Each period is followed by 7 short visits. The follow-up visit will take place during the last short visit of the second period.

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

Besides the set moments for the research, you have a lot of time for yourself. The research centers offer wireless internet, TVs with a DVD or Blue-ray player or Netflix, as well as computers and video game consoles in the living room. You can also play darts, pool and table tennis. Some participants really take this time for themselves. They study or read a book. During longer studies, ICON organizes activities and workshops. 

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. 

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.

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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