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 older than 65 years, you weigh less than 50 kg or you are outside of the limits for Body Mass Index (16 - 32 kg/m2)
  • You are regularly taking prescription and non-prescription medications or supplements, or you are suffering from a chronic illness.
  • You used tobacco / nicotine-containing products or electronic smoking devices within the last 3 months or you have a positive cotinine test.
  • You are currently in Sub-Saharan Africa or have relocated from Sub-Saharan Africa within 6 months of screening.

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 to 65

Sex

Male/female

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

Part 1:

  • You will stay in the PCRU for 1 treatment period, comprised of 3 days and 2 nights.
  • The follow-up procedures will take place approximately at Day 28. The procedures will be conducted via telephone except for female participants of childbearing potential who will have to come to the PCRU to perform a pregnancy test. 
     

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.
 

See calendar

How long is the study?

Approximately 56 days

Compensation

Up to € 880, plus travel fees