Diese Studie enthält eine ausreichend große Teilnehmerzahl. Sie können sich hierfür nicht mehr an- oder abmelden.

Thrombotische und entzündliche Erkrankungen

Ort der Studie

Thrombotische und entzündliche Erkrankungen

Clinical trial of a new compound that has been developed for the treatment of thrombotic, inflammatory, and autoimmune diseases

 

The research physician about this research

The purpose of this trial is to assess the safety and tolerability of a single dose of the study compound when administered as a solution directly into a blood vessel (intravenous infusion) or when administered under the skin (subcutaneous infusion).

 

Important information about this study

  • Since the start, 9 groups have been completed and 32 participants have been dosed
  • In the afternoon and evening you have free time for relaxation, study or work
  • Interim payment of compensation and travel costs after the 2nd short visit

 

Group A6a 9 Tage Aufenthalt
26 Jan 2023 bis einschl. 3 Feb 2023
kurzer Besuch
10 Feb 2023
17 Feb 2023
24 Feb 2023
24 Mär 2023
Nachuntersuchung
21 Apr 2023
€ 3.212
Group A6b 9 Tage Aufenthalt
29 Jan 2023 bis einschl. 6 Feb 2023
kurzer Besuch
13 Feb 2023
20 Feb 2023
27 Feb 2023
27 Mär 2023
Nachuntersuchung
24 Apr 2023
€ 3.212

 

 

Who can participate?

  • You are a healthy male or female
  • You are between 18 and 60 years old
  • You weigh a minimum of  50 kg and a maximum 110 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2.
  • You are not allowed to smoke 30 days before your pre-screening. Smoking is allowed during the medical trial, but smoking is not allowed during your stay in our research center.

 

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to this clinical trial (counting from the follow-up visit). You also may not have participated in 4 or more studies in the 12 months prior to the first administration of this study.
  • 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 meet one of the following conditions:

  • You are using contraception (for example the contraceptive pill or an intrauterine device) in combination with a condom;
  • You have passed the menopause (no period for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You are not sexually active according to your lifestyle;
  • You only have sexual contact with women.

 

As a male you can only participate if you meet one of the following conditions:

  • You are using a condom and your female partner uses an effective contraceptive method (for example the contraceptive pill or an intrauterine device);
  • You have been sterilized or your female partner is sterilized or has passed the menopause;
  • You are not sexually active according to your lifestyle;
  • You only have sexual contact with men.

 

Compensation

  • You will receive a gross compensation of € 3212 for full participation.

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 stays and research

The trial consists of 1 period during which you will stay in the research facility in Groningen for 9 days (8 nights), followed by 4 short visits. The 5th visit will be the follow-up visit and will take place around 2,5 months after your departure from the research facility.

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


 

 

link2trials

© 2024 Link2Trials