Learn more about this research?
- Your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI shows the relation between body weight in
kilograms and length in meters.
- Both non-smokers and smokers are allowed to participate in this study; however, during your stay in the research
facility, smoking is not allowed.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 2.028,- for participation in one of the groups of this study.
Travelling expenses will be reimbursed based on the distance traveled (€0,19 net per kilometer) with a minimum of €12,- and a maximum of €160,- (840 kilometers) per return, regardless of the mode of transportation.
Period of stay and research
The study consists of 1 period during which you will stay in our research facility in Groningen, location UMCG for 7 days (6
nights), followed by 7 short visits.
Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the
currently planned dates; however, these may be subject to change.
Information sheet PRA-170751
Type of study
The purpose of the study is to investigate to what extent the study medication is safe and tolerated. It will also be investigated how quickly and to what extent the study medication is absorbed and eliminated from the body. In addition, the effect on specific white
blood cells will be investigated
The study drug is not registered as a drug and has not been given to humans before. The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
The actual study will consist of 1 period during which you will stay in the clinical research center in Groningen, location UMCG for 7 days (6 nights) followed by 7 days during which you will visit the clinical research center in Groningen, location Martini for a short visit.
Before the start of the study you will visit the medical screening centre in Groningen, location Martini. You will receive the study drug and / or placebo once as an injection under the skin of the abdomen (subcutaneous). Blood samples will be taken regularly during the study.
Risks and medical supervision
All potential drugs cause adverse effects; the extent to which this occurs differs. As the new study drug will be administered to man for the first time in this study, adverse effects of man have not been reported to date. However, it has been studied in animals. The most frequently observed adverse effects in animals were: Increased heart rate in a 13-week study in monkeys. The doses these monkeys received were higher than those given in the current study. The increase in heart rate was believed to be due to overreaction of the immune system (see item 3 below for further details) and skin rash.
You will be under strict medical supervision during the study. Before the study and at the end of the study you will undergo an extensive medical screening.
Conditions for participation
You are a healthy male between 18 and 45 years old. You can only take part in the study if you do not smoke or smoke less than 10 cigarettes per day, however during your stay in the research facility, smoking is not allowed.
The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including products made of chocolate), grapefruit (juice) and tobacco products during the study is not allowed. Also before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine is allowed. Before you are allowed to take part in the study, you will be medically screened; this screening will take place within four weeks before the start of the study.
- Period of stay
- 7 days
- 7 times
- € 2.028,-
Group 10a€ 2.028,-
7 days stay
- 1 Jul 2018 up to and including 7 Jul 2018
- 9 Jul 2018
- 13 Jul 2018
- 16 Jul 2018
- 22 Jul 2018
- 30 Jul 2018
- 13 Aug 2018
- 27 Aug 2018
Group 10b€ 2.028,-
7 days stay
- 3 Jul 2018 up to and including 9 Jul 2018
- 11 Jul 2018
- 15 Jul 2018
- 18 Jul 2018
- 24 Jul 2018
- 1 Aug 2018
- 15 Aug 2018
- 29 Aug 2018
Group 11a€ 2.028,-
7 days stay
- 9 Sep 2018 up to and including 15 Sep 2018
- 17 Sep 2018
- 21 Sep 2018
- 24 Sep 2018
- 30 Sep 2018
- 8 Oct 2018
- 22 Oct 2018
- 5 Nov 2018
Group 11b€ 2.028,-
7 days stay
- 11 Sep 2018 up to and including 17 Sep 2018
- 19 Sep 2018
- 23 Sep 2018
- 26 Sep 2018
- 2 Oct 2018
- 10 Oct 2018
- 24 Oct 2018
- 7 Nov 2018