Who may participate
This study is seeking healthy male and female participants.
Participants must be healthy, meaning they will not have the condition for which this treatment is being developed and are in overall good health.
You may not take part in this study if:
- You are younger than 18 years, or you weigh less than or equal to 50 kg or you are outside of the limits for Body Mass Index (18 – 32 kg/m2).
- You are a woman of childbearing potential.
- You used tobacco / nicotine-containing products or electronic smoking devices within the last 3 months or you have a positive cotinine test.
There are other requirements for participation in this study.
Please read attentively the Informed Consent Document (ICD), more explanation will be provided by the study staff during the screening process.
Condition
Healthy
Age
18 +
Sex
Male/female without childbearing potential
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this study may be a fit for you, you’ll be invited to a screening visit at our facility in Brussels, Belgium.
The study will last for about 11 weeks. You will stay in the PCRU for 2 treatment periods (Period 1 and Period 2), each period comprised of 8 days and 7 nights, with a total stay of 16 days and 14 nights in the PCRU.
The 2 treatment days will be separated by an interval of at least 14 days. The follow-up phone call will take place approximately 28-35 days after the last administration of the study medicine.
You will be screened within 28 days prior to the first dose of study intervention.
Throughout the study, staff will closely monitor your health status and collect data.
You will not personally derive any benefit from your participation in this study, but the results obtained could be very important for the development of medicines and treatments which will benefit other people.
How long is the study?
Approximately 11 weeks
Compensation
Up to € 4.040, plus travel fees