- You are a healthy male or female.
- You are between 18 and 65 years old.
- Your weight is minimal 50 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2.
- You do not smoke and do not use any nicotine-containing products from 3 months prior to the compound administration in the trial.
- 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).
- For this trial, you cannot (have) receive(d) a COVID-19 vaccine within 7 days prior to the start until 14 days after compound administration (in the period after in consultation with the doctor).
- 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.
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 consecutive months);
- You are physiologically incapable of becoming pregnant;
- 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 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;
- You are only sexually active with a partner of the same sex.
- The trial 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 12 short visits including the follow-up.
Note: You must be available for all dates to be able to participate in this clinical trial.
|Group 4c || |
|5 Tage Aufenthalt || |
- 5 Jun 2023 bis einschl. 9 Jun 2023
|kurzer Besuch || |
- 10 Jun 2023
- 13 Jun 2023
- 16 Jun 2023
- 20 Jun 2023
- 27 Jun 2023
- 4 Jul 2023
- 11 Jul 2023
- 18 Jul 2023
- 1 Aug 2023
- 15 Aug 2023
- 29 Aug 2023
|Nachuntersuchung || |
Only women who have passed menopause or have been sterilized can participate.
- You will receive a gross compensation of € 4290 for participation in one of the groups of this study.
Travelling expenses will be reimbursed based on the distance traveled (€ 0,21 net per kilometer) with a minimum of € 13,- and a maximum of € 176,40 (840 kilometers) per round trip, regardless of the mode of transportation.