Study groups
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
WHO CAN PARTICIPATE?
Note:
As a female you can only participate if you meet one of the following conditions:
As a male you can only participate if you meet one of the following conditions:
WHAT IS THE COMPENSATION FOR THIS RESEARCH?
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?
Part A: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights), followed by 5 short visits including the follow-up visit.
Part B: The trial consists of 4 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6). The periods are set-up as follows: The first period is 10 days (9 nights), followed by 2 periods of 3 days (2 nights), concluded by the last period of 6 days (5 nights). After the last period there are 7 more short visits including the follow-up visit
Note: You must be available for all dates to be able to participate in this clinical trial. The location in Groningen is Van Swietenlaan 6 or Hanzeplein 1 (UMCG).
READ MORE ABOUT THE RESEARCH
The trial will investigate how quickly and to what extent the study compound is distributed and eliminated from the body. In addition, it will also be investigated how safe the study compound is and how well it is tolerated when it is used by healthy participants. The effects of the study drugs are compared to the effects of a placebo (drug with no active ingredient).
The study compound has not been administered to humans before, but it has been extensively tested in the laboratory and on animals. This trial is not intended to improve your health but is necessary for the further development of this compound. The trial will only take place after it has been approved by the Independent Ethics Committee (METC).
All potential medicines can cause side effects.
As the compound will be administered to humans for the first time in this trial, side effects in humans are not known yet. The compound has been studied extensively in the laboratory and in animals.
You should take into account that (serious) side effects may occur that are still unknown. In addition to unknown side effects, there is a (small) chance that an allergic reaction will occur. This can be caused by the study compound or other ingredients that are used to prepare the formulation. During the study, you will be under strict medical supervision. The doctors and investigators of ICON are always well-informed about the compound being studied. With this knowledge they can estimate the effects and side effects reasonably well.
This trial will be executed in maximum of 112 healthy male and female participants. The trial consists of 2 parts: part A and part B. You can only participate in one part of this trial.
To check if you are eligible to participate a medical screening will take place before the start of the trial. Depending on availability, this can be performed in Groningen or Utrecht. This screening will take place approximately within 4 weeks before the start of the clinical trial.
Part A: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights), followed by 5 short visits including the follow-up visit.
Part B: The trial consists of 4 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6). The periods are set-up as follows: The first period is 10 days (9 nights), followed by 2 periods of 3 days (2 nights), concluded by the last period of 6 days (5 nights). After the last period there are 7 more short visits including the follow-up visit.
In part A you will receive the new compound once. You will be given the compound or placebo as an intravenous infusion (solution of the compound that will be administered directly in a blood vessel) or as an injection under the skin (subcutaneous) in part A. In part B you will receive the new compound 5 times. You will be given the compound or placebo as an injection under the skin (subcutaneous) in part B.
Prior to screening, (each) admission, the short visits and the follow-up, you have to stay fasted for 4 hours. You can only drink water prior to your visit until 1 hour before due to covid testing. This means that we will ask you to fast prior to any participation in the trial. You have not yet signed the form for participation in the trial. After the screening it will be announced whether you can participate.
There are no specific meals in this study. Consumption of medication, alcohol, poppy seeds, coffee and tea, cola, power drinks and chocolate (including chocolate milk), grapefruit (including juice) are not allowed during the trial. Excessive exposure to sunlight must be avoided during the trial. Also, before the start of the trial and when you are not staying in the research facility, there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also called theine) is allowed.
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!
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.
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.
We pay the compensation for your participation, including travel expenses, within 21 days of the follow-up screening of the trial. If you have questions about the payment, please contact us.