Die Studie

Clinical trial of a new compound that has been developed for the treatment of the coronavirus.

  • You are a healthy male or female.
  • You are between 18 and 65 years old. 
  • Your weight is at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 35.0 kg/m2
  • Only non-smokers are allowed to participate in this clinical trial.

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the screening of this clinical trial (counting from the last dosing).
  • 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 male you can only participate if you meet one of the following conditions:

  • You are using a condom;
  • You remain abstinent (not sexually active) if in accordance with your lifestyle .

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 period for at least 12 months);
  • You have been sterilized at least 6 months prior to the first administration.

Zeitraum

The trial consists of 3 parts: part A, part B and part C. You can only participate in one part of this clinical trial.

  • Part A consists of 1 period during which you will stay in the research facility in Groningen for 6 days (5 nights). The follow-up visit will take place on the day of your departure from the research facility. 25 to 29 days after your departure from the research facility, 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 for 12 days (11 nights). The follow-up visit will take place on the day of your departure from the research facility. 25 to 29 days after your departure from the research facility, you will be contacted by phone for some questions.
  • Part C consists of 1 period during which you will stay in the research facility in Groningen for 16 days (15 nights). The follow-up visit will take place on the day of your departure from the research facility. 24 to 28 days after your departure from the research facility, you will be contacted by phone for some questions.

PLEASE NOTE: You must be available for all dates to be able to participate in this trial. These are the currently planned dates; however, these may be subject to change.

 

Group A3a  

6 Tage Aufenthalt

 
  • 8 Jan 2023 bis einschl. 13 Jan 2023
 

Anmerkung

Follow up by phone on February 9, 2023

 

Group A3b  

6 Tage Aufenthalt

 
  • 10 Jan 2023 bis einschl. 15 Jan 2023
 

Anmerkung

Follow up by phone on February 11, 2023

Aufwandsentschädigung

  • For participation in one of the groups of part A of the trial, you will receive a gross compensation of €1558.
  • For participation in one of the groups of part B of the trial, you will receive a gross compensation of €2413.
  • For participation in part C of the trial, you will receive a gross compensation of €2861.

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