• The study compound is being developed for the treatment of infections. Infections occur when viruses, bacteria, fungi, or parasites (so-called "pathogens") invade the body and begin to grow. If the immune system is strong enough, such a pathogen is less likely to cause an infection. But if the immune system is weakened, the body can no longer effectively protect itself against it, and the person becomes ill. The study compound is being developed for the treatment of bacterial infections.
• The trial consists of three parts. You can only participate in one part.
• In this trial, we will examine the safety of the new compound and how well it is tolerated when used by healthy participants. We will also investigate how quickly the new compound is eliminated by the body.
• A solution of the study compound is administered directly into a blood vessel via an intravenous infusion..An administration takes around one hour. In Part A, the compound will be administered once. In Part B, the compound will be administered once daily for 7 days. In Part C, the compound will be administered twice daily for 7 days.

All (possible) 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. 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.
• You are at least 18 and at most 55 years old.
• Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18.0 and at most 30.0 kg/m². 
• You do not smoke (vaping included), and you have not used any nicotine-containing products in the 6 months prior to the first compound administration in this trial.

• 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 intrauterine device containing hormones) in combination with a condom;
  • You are using a copper intrauterine device in combination with a condom;
  • You have passed menopause (no periods for at least 12 months);
  • You have been sterilized, or your male partner has been sterilized;
  • You are only sexually active with a partner of the same sex;
  • You are not sexually active
     
• As a male you can only participate if you meet one of the following conditions:
  • You are using a condom during intercourse with your fertile female partner;
  • Your female partner is sterilized or has passed menopause (no periods for at least 12 months);
  • You are only sexually active with a partner of the same sex;
  • You are not sexually active

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 of the previous trial). 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.

Part A: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 7 days (6 nights). The follow-up will take place by phone 3 – 7 days after discharge.

Part B and C: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 13 days (12 nights). The follow-up visit will take place 1 – 5 days after your departure from the research facility.

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