Muskel- und Nervenzustände

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

The research physician about this research

• In this study the safety and tolerability of the study compound is investigated when administered to healthy volunteers.
• The trial consists of 2 parts: part A and part B. You can participate in one part of the trial.
• The study compound can possibly be used for the treatment of neuromuscular diseases (muscle control diseases). This type of disease is caused by a defect in transmission of signals from nerve cells to muscles. This can result in fluctuating muscle weakness of the arms/legs, eyes or face and can be life threatening. Current treatments for muscle control diseases are focused on treating the symptoms of the disease. The study compound is being developed to maintain and restore the cell signal transmission and to possibly counteract effects from the muscle control diseases.    

Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können. 

Important information about this study

• After the fourth short visit, we will transfer half of the reimbursement to you
• This trial started on February 20, 2023 and 10 groups have already started
• The short visits of this clinical trial can also take place in Utrecht
• Please note: as a female you can only participate if you are no longer fertile.

Who can participate?

• 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.

Compensation

• You will receive a gross compensation of € 7.693 for participation in one of the groups of part B.

Travel 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.

Period of stay and research

• Part B of the trial consists of 3 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 10 days (9 nights) during the first period. The second period of stay will be 3 days (2 nights) and the final period of stay will be 9 days (8 nights). The period(s) of stay in the clinic will be 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.