Die Studie

Clinical trial of a new compound that is being developed for the treatment of neuromuscular diseases.

  • You are a healthy male or female.
  • You are between 18 and 65 years old.
  • Your weight is between 50 kg and 100 kg and your Body Mass Index (BMI) is between 18.0 and 30.5 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 3 months prior to the first compound administration in this clinical trial (counting from the last compound administration).
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening including physical exam and laboratory tests. Depending on availability, this can be performed in Groningen or in Utrecht.

As a female you can only participate if you 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 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.

 

Zeitraum

The trial consists of 2 parts: part A and part B. You can participate in one part of the trial.

  • Part A of the trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 9 days (8 nights), followed by 9 short visits. The short visits will be spread out over a 5 month period. The follow-up visit will take place during your last short visit.

Note: You must be available for all dates to be able to participate in this clinical trial.

 

 

Group A01b  

9 Tage Aufenthalt

 
  • 22 Feb 2023 bis einschl. 2 Mär 2023
 

kurzer Besuch

 
  • 9 Mär 2023
  • 16 Mär 2023
  • 23 Mär 2023
  • 30 Mär 2023
  • 13 Apr 2023
  • 27 Apr 2023
  • 25 Mai 2023
  • 22 Jun 2023
 

Nachuntersuchung

 
  • 22 Jul 2023
 

 

Group A02a  

9 Tage Aufenthalt

 
  • 23 Mär 2023 bis einschl. 31 Mär 2023
 

kurzer Besuch

 
  • 7 Apr 2023
  • 14 Apr 2023
  • 21 Apr 2023
  • 28 Apr 2023
  • 12 Mai 2023
  • 26 Mai 2023
  • 23 Jun 2023
  • 21 Jul 2023
 

Nachuntersuchung

 
  • 20 Aug 2023
 

 

Group A02b  

9 Tage Aufenthalt

 
  • 27 Mär 2023 bis einschl. 4 Apr 2023
 

kurzer Besuch

 
  • 11 Apr 2023
  • 18 Apr 2023
  • 25 Apr 2023
  • 2 Mai 2023
  • 16 Mai 2023
  • 30 Mai 2023
  • 27 Jun 2023
  • 25 Jul 2023
 

Nachuntersuchung

 
  • 24 Aug 2023
 

Aufwandsentschädigung

  • You will receive a gross compensation of € 4589 for participation in one of the groups of part A.

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.