• For this trial, we are looking for participants of European ancestry. This information focuses on participants of European descent.
• In this study we will investigate how safe the new compound is and how well it is tolerated when it is used by healthy participants of different ancestries.
• The study compound is a new compound that may potentially be used for the treatment of a kidney disease called autosomal dominant polycystic kidney disease (ADPKD). This kidney disease is a hereditary condition in which cysts gradually develop in the kidneys. A cyst is a fluid-filled sac (a kind of sac). These cysts often lead to kidney enlargement and high blood pressure. Eventually, so many cysts can grow that they crowd out normal kidney tissue. The kidneys then stop functioning properly. ADPKD is one of the most common hereditary kidney diseases, usually presenting symptoms in adults. The new compound is developed to block signals in the body that make the cysts in the kidney grow. This can cause the kidneys to grow more slowly and function longer. However, this does not cure the disease.
• You will be given the study compound once as four injections of 1.5 mL under the skin of the abdomen.

The compound has been tested in healthy individuals and patients with ADPKD.

At this stage of development, the following potential risks are associated with the study compound:

• May affect an unborn child. Women who could become pregnant cannot take part (the compound is not transmitted via sperm).
• Possible effects on bone and muscle growth or repair.
• Possible slower wound healing.
• Possible changes to metabolism.
• Possible effects on the immune system, which may cause it to react abnormally in rare cases. Possible effects on the thyroid gland, a gland that influences things like appetite, food absorption, body temperature, heart rate, blood pressure, and energy.
• Allergic‑type reactions, including rare immediate hypersensitivity.
• Injection‑site reactions such as pain, redness or swelling.

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 the screening physician or nurse any questions you may have. Once everything is clear to you, you can decide whether 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 and your 2 parents and 4 grandparents were born in Europe.
• You are at least 25 and at most 55 years old.
• Your weight is at least 50 kg (males) and 45 kg (females) and your Body Mass Index (BMI) is at least 18.0 and at most 28.0 kg/m². 
• Both non-smokers and smokers or occasional smokers 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 have passed menopause (no periods for at least 12 months);
  • You have been sterilized.
• The are no contraceptive requirements for males.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first administration of the compound in this clinical trial (counting from the last compound administration). This may be longer for certain trials. Please contact us for more information.
• 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 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 9 days (8 nights), followed by 6 short visits. The follow-up will take place during the final short visit.

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