Immunerkrankungen

The trial

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

• You are a healthy male or female.
• You are at least 18 and no older than 55 years old.
• Your Body Mass Index (BMI) is between 18 and 32 kg/m2. 
• You do not smoke and you do not use any nicotine-containing products.

Note:

• You cannot participate in the trial if you have participated in another drug clinical trial in the 90 days prior to the first compound administration in this clinical trial (counting from the last administration).
• For this trial, you cannot (have) receive(d) a COVID-19 vaccine within 3 days prior to the start and during this trial.
• To determine if you are eligible 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 from screening until 90 days after the follow-up visit:
  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones);
  • You are using a copper intra-uterine device;
  • You have passed the menopause (no periods 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 are only sexually active with a partner of the same sex.
• As a male you can only participate if you meet one of the following conditions from screening until 90 days after the follow-up visit:
  • You are using a condom in combination with an additional contraception method used by your fertile female partner;
  • You are using a condom and 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 are using a condom if your partner is pregnant.

Period

The trial consists of 2 parts: part 1 and part 2. You can only participate in one group of this trial.

Part 1 consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 5 days (4 nights). The follow-up visit will take place 10 to 14 days after your departure from the research facility.

Part 2 group 4 has one additional screening visit prior to the start of the trial. The additional visit takes place within 14 days prior to the start of the trial where you are tested for the bacteria causing meningococcal disease. The trial starts with 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 18 days (17 nights). The follow-up visit will take place 10 to 14 days after your departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.

Compensation

For participation in group 4 of part 2, you will receive a gross compensation of €3820.

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.