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. In addition to the criteria listed, participants must meet the following requirements:   

  • Willing and able to travel to our study facility in Brussels, Belgium
  • Able to comply with study appointments and procedures
  • For women:
    • Women of non-childbearing potential:
      • This means that:
        • you are post-menopausal (meaning that your last period was at least one year ago), or
        • you have been surgically sterilised (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
    • Women of childbearing potential:
      • If you are considered as being capable of having children and you take part in this study, you must use contraception. At each visit to the PCRU, the investigator or PCRU staff will check you are using the appropriate method(s) of contraception.
  • For men:

    • No contraception methods are required for male participants in this study, given that research has shown that the study drug does not transfer through semen.

       

    • Body mass index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg. 

 

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 75 years old

Sex

Male and Female

Long-term follow-up

A follow-up call at the end of the study

How long is the study?

Approximately 3 months

Compensation

€ 1 694.00

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. 

If you choose to participate, you will be in the study for up to 9 weeks, including the screening and follow-up period. 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.

Study Calendar