Alter von 18 bis 55
Nur für Frauen, die keine Kinder mehr gebären können
BMI von 18.5 bis 30
Clinical trial of a new compound that is being developed for the treatment of autoimmune diseases
The research physician about this research
- In this clinical trial we will investigate how safe the study compound is and how well this is tolerated when it is used by healthy participants. The trial is divided into two parts: part 1 and part 2. You can only participate in one part.
As a female, you can only participate in this study if you have passed the menopause or have been sterilized. Does this not apply to you? Click here for the studies in which fertile women can participate.
Important information about this study
- You will receive the compound in the form of a drink
- After your stay there will only be a follow-up by phone, so you don't have to come back
- In part 1 of the study you will only receive the drug once
|Group 1.1a||8 Tage Aufenthalt
25 Jan 2023 bis einschl. 1 Feb 2023
Follow-up by phone at February 23, 2023
|Group 1.1b||8 Tage Aufenthalt
26 Jan 2023 bis einschl. 2 Feb 2023
Follow-up by phone at February 24, 2023
Who can participate?
- You are a healthy male or female.
- You are between 18 and 55 years old.
- Your weight is at least 50kg.
- Your Body Mass Index (BMI) is between 18.5 and 30.0 kg/m2.
- You do not smoke and do not use any nicotine-containing products.
- You cannot participate in the trial if you have participated in another clinical trial in the 60 days prior to the screening of this clinical trial (counting from the follow-up visit).
- For this trial, you cannot (have) receive(d) a COVID-19 vaccine within 2 weeks prior to the start until discharge from the research facility.
- 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 menopause (no menstrual 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 with your fertile 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 according to your lifestyle;
- You are only sexually active with a partner of the same sex.
You will receive a gross compensation of €1650 for participation in one of the groups of part 1.
For participation in one of the groups of part 2 of the trial, you will receive a gross compensation of €4310.
Travel expenses will be reimbursed based on the distance traveled (€ 0.19 net per kilometer) with a minimum of € 12 and a maximum of € 160 (840 kilometers) per round trip, regardless of the mode of transportation.
Period of stay and research
The trial consists of 2 parts: part 1 and part 2. You can only participate in one part of this clinical trial.
- Part 1 consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 8 days (7 nights). 15 to 29 days after your departure from the research facility, you will be contacted by phone for some questions.
- Part 2 consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 22 days (21 nights). 14 to 28 days after your departure from the research facility, 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.