• The study compound is a new compound that may potentially be used for the treatment of type 1 diabetes. Diabetes is a condition where the body struggles to control sugar levels in the blood. People with type 1 diabetes need insulin because their body doesn’t make it anymore. Insulin is the hormone that regulates blood sugar levels.
• In this study we will investigate how quickly and to what extent the study compound is absorbed, transported, and eliminated from the body.
• The study compound has been administered to humans before.
• You will receive the study compound twice as a under the skin (subcutaneous) injection (in the abdomen, arm or thigh).
• The trial consists of 2 parts. You can only participate in 1 part.

The compound has already been tested in healthy participants. In studies with the study compound in humans, the most frequently reported side effects were related to the gastro‑intestinal tract such as: nausea, diarrhea, vomiting, abdominal pain, uncomfortable inability to digest food, difficulties passing stool (constipation) and decreased appetite. Abnormally low blood sugar was also reported as a side effect. Some symptoms of low blood sugar include shakiness, confusion, sweating, dizziness and hunger. The side effects experienced by people who have taken the study compound were generally mild and of short duration.

You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, 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. Once everything is clear to you, you can decide to give written consent to participate in the trial. 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.
• You are at least 18 and at most 65 years old.
• Your your Body Mass Index (BMI) is at least 25.0 and at most 45.0 kg/m2. 
• Both non-smokers and smokers or occasional smokers are allowed to participate in this clinical trial (at most 10 cigarettes per day). 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) in combination with a condom;
  • You are using a copper intra-uterine device in combination with a condom;
  • 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 (for example the contraceptive pill);
  • 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 compound administration in this clinical trial (counting from the follow-up visit).
• 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 trial consists of 2 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 8 days (7 nights) in period 1 and 7 days (6 nights) in period 2. Each period is followed by 2 short visits. The follow-up visit will take place after the last short visit.

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.