This trial will be executed in healthy male and female participants. This trial consists of two parts: part A and part B. Part B is divided in cohort 1 to 3 and cohort 4. You can participate only once in this trial.
To check if you are eligible to participate a medical screening will take place before the start of the trial. Depending on availability, this can be performed in Groningen or Utrecht. This screening will take place within 4 weeks before the start of the clinical trial.
Part A of the trial consists of 1 period during which you will stay in the research facility in Groningen for 6 days (5 nights), followed by 5 short visits to the research facility, and a final follow-up visit 4 weeks thereafter. The total study duration from dosing until the final follow-up visit will be approximately 85 days.
Cohorts 1 to 3 of part B of the trial consist of three 2-week periods. The first period has a stay of 4 days (3 nights) and the next two periods have a stay of 3 days (2 nights) in the research facility in Groningen. Each stay is followed by two short visits to the research facility. After these three periods, another three short visits to the research facility will follow, and a final follow-up visit 4 weeks thereafter. The total study duration from dosing until the final follow-up visit will be approximately 113 days.
Cohort 4 of part B of the trial consists of three 4-week periods. The first period has a stay of 4 days (3 nights) and the next two periods have a stay of 3 days (2 nights) in the research facility in Groningen. Each stay is followed by three short visits to the research facility. After these three periods, another two short visits to the research facility will follow, and a final follow-up visit 4 weeks thereafter. The total study duration from dosing until the final follow-up visit will be approximately 141 days.
You will be given the study compound or placebo as an intravenous infusion (solution of the compound that will be administered directly in a blood vessel). In part A, you will receive the study compound or placebo once. In cohort 1 to 3 of part B, you will receive the study compound or placebo three times, once every two weeks. In cohort 4 of part B, you will also receive the study compound or placebo three times, but then once every four weeks. Whether you will receive the study compound or placebo will be determined by chance.
During the trial, blood will regularly be drawn and urine will be collected. Prior to the screening visit, (each) entry into the research center and the final follow-up visit, you will have to stay fasted for 4 hours. You can only drink water prior to your visit. This means that we will ask you to fast prior to the screening in the screening center. You will not yet have signed the form for approval of participation in the study, but that will be done before the screening starts. After the screening it will be announced whether you can participate.Use of medication, herbal medications, vitamin preparations and other food supplements, and consumption of alcohol, coffee, tea, cola, power drinks, chocolate (including chocolate milk), grapefruit, tangelo, pomelo, Seville oranges (including their juices or marmalade), poppy seeds, tobacco and other nicotine containing products are not allowed during the trial. Also, before the start of the trial and when you are not staying in the research facility, there will be restrictions for some of these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also called theine) is allowed.
