Die Studie

Die Studie ist in Englisch. Um Teil zu nehmen, müssen Sie der englischen oder holländischen Sprache mächtig sein.

Study of an investigational compound that is being developed for the treatment of chronic hepatitis B.

  • You are between 18 and 45 years old and are living in The Netherlands, Belgium or Germany.
  • You do not smoke or do use other nicotine containing products
  • Your Body Mass Index (BMI) is between 19.0 and 30.0 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
  • Women are only allowed to participate in this study if they are using non-hormonal contraception (intrauterine device, IUD) or if they (or their partner) have been surgically sterilized.
  • Men with fertile female partners are allowed to participate only if they are using a condom in combination with a contraceptive measure by their female partner or if they have been surgically sterilized.
  • You cannot have participated in another clinical trial in the 60 days before the start of this study.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. This will be performed in Groningen. When you pass the medical screening a second appointment will be made to perform an X-ray of the chest.

Zeitraum

The study consists of maximally 4 groups. Based on the results in the previous group(s), it will be decided if the next group will be performed.

Group 1 consists of 1 period during which you will stay in our research facility in Groningen for 24 days (23 nights).
Groups 2 & 3 consist of 1 period during which you will stay in our research facility in Groningen for 18 days (17 nights).
Group 4 consists of 1 period during which you will stay in our research facility in Groningen for 13 days (12 nights).
For all groups there will be a follow-up visit between 5 and 9 days after discharge from the research facility.

Group period of stay
1f 8 Nov 2020 up to and including 1 Dec 2020
4f 16 Nov 2020 up to and including 28 Nov 2020
1g 30 Nov 2020 up to and including 23 Dec 2020

Follow-up by appointment.

Please note: You have to be available for all dates of the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.

Aufwandsentschädigung

You will receive a gross compensation of €3608 for participation in group 1 of this study.

For participation in groups 2 or 3 of the study, you will receive a gross compensation of €2786.

For participation in group 4 of the study, you will receive a gross compensation of €2166.

Travelling 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 return, regardless of the mode of transportation.