You will receive a gross compensation of € 3422 for participation in one of the groups of part A. For participation in one of the groups of part B of the trial, you will receive a gross compensation of € 7213. Travel expenses will be reimbursed based on the distance traveled (€ 0.23 net per kilometer) with a minimum of € 14.23 and a maximum of € 193.20 (840 kilometers) per round trip, regardless of the mode of transportation.

• You are a healthy male or female.
• You are at least 18 and no more than 65 years old.
• Your weight is at least 50 kg and no more than 120 kg and your Body Mass Index (BMI) is at least 18.0 and at most 30.5 kg/m2.
• Only non-smokers (not having smoked for 3 months prior to screening) are allowed to participate in this clinical trial.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 12 weeks prior to medical screening in this clinical trial (counting from the last compound administration). Please note that some study drugs remain in your blood longer than 12 weeks. Please contact us for more information about what this implies for your participation in this study.
• To determine if you are suitable to participate in this trial, you will undergo a medical screening including physical exam and laboratory tests. 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 have passed the menopause (no periods for at least 12 months);
  • You have been sterilized;
• As a male you can only participate if you meet one of the following conditions:
  • You are using a condom with your female partner;
  • 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 from the medical screening until 63 days after the last compound administration;
  • You are only sexually active with a partner of the same sex.

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. The studies in monkeys did not show any side effects that might occur in humans. Based on the way this study compound works you could have an increased chance of infections. You may have an immune reaction while receiving the study compound such as itching, rash, and in rare cases, allergic/anaphylactic reactions. If the immune system reacts too strongly, this could potentially cause proteins called cytokines to increase. When the body has a large increase in cytokines, it could lead to Cytokine Release Syndrome (CRS) with symptoms such as fever, low blood pressure, or trouble breathing. These immune proteins will be monitored throughout the study.”

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 healthy male and female participants. The trial consists of two parts. You can participate only once in this trial, and only in one of the two parts.

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 within 4 weeks before the start of the clinical trial.

Part A of the trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 9 days (8 nights), followed by 5 short visits. The follow-up visit (last safety check) will take place during your last short visit. Part B of the trial consists of 2 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 17 days (16 nights) during the first period. The second period of stay will be 9 days (8 nights). The period(s) of stay in the clinic will be followed by 5 short visits. The follow-up visit will take place during your last short visit.

In part A you will receive the study compound once. In part B you will receive the study compound once weekly (4 times in total, same dose each time). In both parts you will be given the study 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). Whether you will receive the study compound or placebo will be determined by chance.

During the trial, blood will regularly be drawn and urine will be collected. Prior to screening, admission, and the follow-up, you have to stay fasted for 4 hours. Fasting is not required for the ambulatory visits. You can only drink water prior to your visit. 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.

Consumption of medication, alcohol, coffee and tea, cola, power drinks and chocolate (including chocolate milk), grapefruit (including grapefruit juice), poppy seeds and tobacco/nicotine-containing products are not allowed 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.

If you are participating in a trial for which you have to stay at the research center for longer than ten days, it is sometimes possible to have visitors (in consultation).

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.

The amount of money you receive for your participation in a clinical trial is determined by the duration of the trial. The longer the trial takes, the higher the compensation. But there are also other factors that determine the amount of the compensation awarded, such as special medical procedures.

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.