• In this study, the effectiveness and safety of different doses of a new contrast agent will be investigated when administered to healthy people. A contrast agent is a liquid that is administered when making medical images (an MRI scan, for example) to better distinguish different tissues in the body from each other. In this study, a solution of the contrast agent will be administered through an IV.  
• The study compound has already been studied in humans before. It has also been extensively tested in the laboratory and in animals. In a previous study with 15 healthy subjects, various doses were tested. No important changes were found in vital signs (such as blood pressure and heart rate). From physical examinations, tests related to the nervous system, heart recordings and blood values, it also did not appear that the investigational drug had a significant effect on the participants. Based on the completed study with 15 healthy subjects, the following side effects could occur: taste disorder, dizziness, headache and changes in heartbeat recording.  You may also experience other, as yet unknown, side effects. Prior to the medical screening, you will receive written information about the study, which also describes the possible side effects. This information will also be discussed with you at the start of the medical screening. You can then ask questions to the screening physician or nurse. When everything is clear to you, you can decide to give written consent to participate in the study. Only then will the measurements of the medical screening take place. We want to emphasize that even after giving written consent, participation in any study is voluntary. You can decide at any time not to participate or to stop the medical screening or the study. You do not need to provide a reason for why you no longer wish to participate. There is another study, currently ongoing, that is dedicated to the cardiac changes in healthy participants. According to the results that have emerged so far from this study, there is no evidence that these cardiac changes are caused by the contrast agent. Overall, the doses of the study compound were safe and well-tolerated, including the doses that will be used in the current study.
• During each period of stay, an MRI scan of the head-and-neck region will be done before and after administration of the study compound. An MRI scan is a medical imaging method using powerful magnets, radio waves, and a computer to make detailed images of the organs in the body. The MRI scanner is a large, doughnut-shaped machine with a hole in the center through which a special bed can move. To participate, you must not be claustrophobic, meaning you should not have a fear of being trapped or confined in enclosed spaces (in this case, the scanner). An MRI scanner does not use radiation.

• You are a healthy male or female.
• You are at least 18 and at most 60 years old.
• You weigh at least 40 kg (for females) / 50 kg (for males) and no more than 120 kg (for both males and females) and your Body Mass Index (BMI) is higher than or equal to 18.0 and lower than or equal to 32.0 kg/m².
• Both non-smokers and light smokers (maximum of 5 cigarettes per day) are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.
   
• As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones);
  • You are using a copper IUD;
  • 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 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 according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first administration in this clinical trial (counting from the last administration in the previous study).
• 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. The medical screening consists of two separate visits. After the normal medical screening at ICON, there will also be an extra visit for an MRI scan.

The trial consists of 4 short periods during which you will stay in the research facility in Groningen (location Hanzeplein 1) for a minimum of 2 days (1 night)  and a maximum of 3 days (2 nights) per period. Each period will be separated by 3 to 7 days. The follow-up will be done on the day of discharge of the last period.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.