Group 5a
- 10 up to and including 15 July
Period(s) of stay (6 days)
- 10 up to and including 15 July
- 18 July
- 25 July
- 8 August
- 5 September
Visit(s)
- 18 July
- 25 July
- 8 August
- 5 September
- 3 October
Follow-up
- 3 October
- €2629,-
Compensation
- €2629,-
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 18.5 and 32 kg/m2
Good to know about this trial
- Short period of stay
- Light smokers are allowed to participate
Study groups
Register without obligation for the group of your preference
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
Additional information
- Part A consists of one in-house period and a follow-up period in which you will receive the new compound once.
- Part B consists of four in-house periods and a follow-up period. You will receive the new compound 5 times.
WHO CAN PARTICIPATE?
Target group
- You are a healthy male or female.
- You are between 18 and 60 years old.
- Your Body Mass Index (BMI) is between 18.0 and 32.0 kg/m2.
- Both non-smokers and light smokers or occasional smokers (who smoke no more than 5 cigarettes per day) are allowed to participate in this clinical trial. From one week prior to admission and during your stay in our research facility you are not allowed to smoke.
Note:
- You cannot participate in the clinical trial if you have participated in another clinical trial in the 3 months prior to the first administration of the compound in this trial (counted from the follow-up).
- COVID-19 vaccines are allowed up to the day before your stay at our clinic.
- Do you have a vaccination appointment planned, or have you recently been vaccinated and do you want to know whether you can participate in this study? Feel free to contact us to discuss the possibilities.
- 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 meet one of the following conditions:
- You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) from at least 4 weeks prior to admission;
- You are using a copper intra-uterine device from at least 4 weeks prior to admission.
- 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 from at least 4 weeks prior to your admission;
- 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 € 2,629 for participation in one of the groups of part A.
- From group 10a onwards you will receive a gross compensation of € 2,733
- For participation in group B1 you will receive a compensation of € 6,578.
- For participation in one of the groups from group B2, you will receive a gross compensation of € 6,834.
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
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
Other information
-
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).
-
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.
-
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.
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.
-
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!
-
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.