• The study compound is a new compound that may potentially be used for the treatment of cholestatic liver diseases. In this liver disease, bile acids are not sufficiently transported from the liver to the small intestine, leading to their accumulation in liver cells. Ultimately, this process can lead to liver inflammation and damage.
• In this trial, we will investigate how safe the new compound is and how well it is tolerated when it is used by healthy participants. We will also investigate how quickly and to what extent the study compound is absorbed, transported, and eliminated from the body. In addition, we will look at the effect of the study compound on several compounds in the blood and urine (for example, bile acids and antibodies) that can help to understand how the study compound affects the body.
• The study compound has not been administered to humans before. It has been extensively tested in the laboratory and on animals.
• In this trial you will receive the study compound by injection four times.

All (potential) medicines can cause side effects. Because the compound has not yet been administered to humans, there are currently no known side effects in humans. In rare cases (<0.1%), serious side effects can occur during the first administration to humans.

Based on the way study compound works, the following side effects may occur: increased bile acids in blood, this can, for example, lead to itching and increased liver enzymes.

These effects are dose-dependent and there is little chance that they occur with the doses selected for this study. Furthermore, these side effects are transient and, except for stomach or intestinal irritation and flu-like symptoms, you will probably not notice these. In addition, if occurring, these effects probably do not have clinical implications.

The compound has already been extensively tested in the laboratory and on animals. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects based on these animal tests. 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. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.

• You are a healthy male or female (postmenopausal).
• You are at least 18 and at most 55 years old.
• Your weight is at least 55 kg and at most 100 kg and your Body Mass Index (BMI) is at least 18.0 and at most 30.0 kg/m2. 
• Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (maximal 5 cigarettes per day). During your stay in our research facility and 24 hours before every admission you are not allowed to smoke.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the follow-up visit). For some study compounds this can be 90 days. This will be discussed during your telephone screening.
• 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 the following conditions:
  • You have passed menopause (no periods for at least 12 months).
• As a male you can only participate if you meet one of the following conditions:
  • You use 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 according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

The trial consists of 5 periods during which you will stay in the 1^st period in the research facility in Groningen (location van Swietenlaan 6) for 5 days (4 nights), followed by 2 short visits.

From the 2^nd period to the 4^th period you will stay in the research facility for 3 days (2 nights) each time.

During the 5^th period you will stay for 4 days (3 nights) in the research facility, followed by 6 short visits. The follow-up visit will take place during the last short visit.

Note: You must be available for all dates to be able to participate in this clinical trial.