• The study compound is being developed for the treatment of malaria, and has been administered to healthy people before in a previous clinical trial. Malaria is a disease caused by a parasite. The parasite is spread to humans through the bites of infected mosquitoes. People who have malaria usually feel very sick with a high fever and shaking chills.
• In this clinical trial, we investigate how the study compound is processed and eliminated by the body and how well it is tolerated when it is used by healthy participants.
• A solution of the study compound is taken directly into a blood vessel, as an infusion or injection.
• During the trial, your heart will be constantly monitored once or twice for 25-hours. You will receive stickers (electrodes) on your chest that are attached to a device. At various times you need to lie still for 10 minutes without moving, talking or sleeping. You will also not be able to listen to music, watch TV or use a laptop or telephone. This is allowed outside these moments, 
• The trial consists of 2 parts: part A and part B. In part A you receive the study compound once, in part B you receive the study compound once daily for 3 days.

The compound has already been studied in the laboratory, animals, and – in a different form – in healthy people (as a capsule taken by mouth).  The compound has not been administered as an infusion or injection to healthy humans yet. The following side effects are most often observed: nausea, vomiting, diarrhea, and abdominal pain.

You may also experience other, 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 during 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 study. 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.

• 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 32.0 kg/m2. 
• You do not smoke and do not use any nicotine-containing products.
• 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 the menopause (no periods for at least 12 months);
  • You have been sterilized.
• 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 are using a condom, and you or your female partner have been sterilized;
  • You are using a condom, and your female partner has passed the menopause (no periods for at least 12 months);
  • You are using a condom with your male partner;
  • You are not sexually active according to your lifestyle.

Note: 

• You cannot participate in the trial if you have participated in another clinical trial in the 90 days prior to the first compound administration in this clinical trial (counting from the last dosing 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 trial consists of 2 parts: part A and part B. You can take part only in one of the study parts.

Part A consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 5 days (4 nights), followed by 6 short visits. The follow-up visit will take place during the last short visit. 6 to 10 days after the follow-up visit, you will be contacted by phone for some questions.

Part B consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 7 days (6 nights), followed by 6 short visits. The follow-up visit will take place during the last short visit. 6 to 10 days after the follow-up visit, you will be contacted by phone for some questions

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.