Study of a new investigational compound for the treatment of autoimmune and inflammatory diseases
- Both nonsmokers and light smokers can participate, but you need to be able to abstain from smoking and using nicotine containing products during your stay in the clinical center.
- You have a white or slightly tinted skin
- You are between 20 and 55 years old
- Your weight is between 45 and 110 kg and your Body Mass Index (BMI) is between 18 and 30 kg/m2.
- Females are only allowed to participate in this study if they:
- Have been postmenopausal for at least one year and are between 45 and 55 years old.
- Have been surgically sterilized at least 6 months ago.
- To determine if you are eligible to participate in this study, you will undergo a medical screening in our medical screening facility.
You will receive a gross compensation of € 1.421 for full 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
For each group the study consists of 1 period during which you will stay in our research facility in Groningen for 5 days (4 nights), followed by 6 short visits.
If the dates do change you will be notified as soon as possible.
The medical screening for this study will take place in the screening center in Groningen or Utrecht.
Type of study
Soon a research study will start at PRA with a new drug that may be used for the treatment of autoimmune and inflammatory diseases. The purpose of the study is to investigate how safe the study medication is and to what extent the study medication is absorbed, tolerated and eliminated. Also it will be investigated what the effect is on the the body. The study compound is not registered and is in earlier groups of this study administered to humans for the first time. It has been previously tested in the laboratory and on animals.
This study is not intended to improve your health, but is necessary for the further development of this study medication. The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
For each group the study consists of 1 period were you will stay for 5 days (4 nights) in our research facility in Groningen (location Martini), followed by 6 short visits. During the study you will receive the study medication or placebo (compound without an active ingredient) once after your breakfast. The medication will be given as an intravenous infusion for 1 hour or 4 hours or another duration, depending on the group in which you will participate. The responsible doctor will inform you about the infusion duration at admission in our research facility.
Based on the results of earlier groups it has been decided to give paracetamol, antihistamine and possibly a glucocorticoid to the volunteers in group 2B and 3 as a pre-treatment prior to starting the infusion with the study compound. This is done to minimize the occurrence of side effects associated with infusion-related reactions, such as headache and raised temperature. Antihistamines suppress allergic reactions and glucocorticoids suppress the immune system. If you will receive a glucocorticoid is depending of the group you will participate in.
For group 4 till group 7 may be decided, based on the results of the previous group(s), to pre-treat the volunteers before the infusion with paracetamol, an antihistamine and possibly with a glucocorticoid when this is deemed necessary. The responsible doctor will inform you if this is applicable to the group or subgroup you participate in and will also inform you which other medication you will possibly receive.
Upon admission to the clinic you must have fasted for at least 4 hours. You can find the exact dates of each group on our website. If the dates do change you will be notified as soon as possible. Before the start of the study you will visit the medical screening centre for a medical screening. Blood samples will be taken regularly during the study.
Risks and medical supervision
All drugs have the potential to cause adverse events. This study compound is administered to man for the first time in an earlier group of this study, because of this, there are currently not many side effects known. The most important side effects reported in group 1 of this study were as follows: one volunteer with a moderate headache and one volunteer with a moderate event of low blood pressure. Both events resolved the same day. The following mild complaints were reported by more than one volunteer after administration of the study compound: headache, cold feeling, weak feeling legs, lowering blood pressure, inflammation at the infusion site, common cold, and tenderness of calve/hamstrings. All complaints resolved and were short of duration.
In animal studies, the study medication was generally well tolerated when administered. No adverse findings were noted which would lead to a specific expectation of a side effect in this study. You should be aware that adverse effects may occur during the study. 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 or female with a white or slightly tinted skin between 20 and 55 years old. Your body weight is between 45 and 110 kg and your Body Mass Index (BMI) is between 18 and 30 kg/m2 (the BMI reflects the relation between your body weight in kilograms and your height in meters). You are only allowed to participate in the study if you are a light smoker or do not smoke and you are able to abstain from smoking and using nicotine containing products during your stay in the clinical center. As a female volunteer you are only allowed to participate in this study if you are sterilized at least 6 months ago and you are between 20 and 55 years old or if you have been postmenopausal for at least one year and you are between 45 and 55 years old.
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 and during each period there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also mentioned theine) is allowed. Before you are allowed to take part in the study, you will be medically screened. The screening will take place within three weeks before the start of the study.
5 days stay
- 11 Jul 2019 up to and including 15 Jul 2019
- 19 Jul 2019
- 26 Jul 2019
- 2 Aug 2019
- 9 Aug 2019
- 23 Aug 2019
- 5 Sep 2019
5 days stay
- 25 Jul 2019 up to and including 29 Jul 2019
- 2 Aug 2019
- 9 Aug 2019
- 16 Aug 2019
- 23 Aug 2019
- 6 Sep 2019
- 19 Sep 2019