For the treatment of RSV (respiratory syncytial virus) infection.
You are being invited to take part in a clinical study to evaluate an investigational medicinal product. An investigational medicinal product is a medicinal product that is still being studied to evaluate its efficacy, safety or mode of action.
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 procedure
- For Japanese participants only:
- You must have 4 biological Japanese grandparents who were born in Japan
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.
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 sterilized (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
- At each visit to the PCRU, the investigator or PCRU staff will check that you are using the appropriate method(s) of contraception.
- Women of non-childbearing potential. This means that:
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 60
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
If this study may be a fit for you, you’ll be invited to a screening visit at our facility in Brussels, Belgium.
This study includes 3 parts.
- Part 1 of the study is planned to last approximately 16 weeks.
- Part 2 of the study is planned to last approximately 10 weeks.
- Part 3 of the study is planned to last approximately 10 weeks.
You will participate in one of the three parts.
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 16 weeks
Compensation
Up to €7 865.00, plus travel fees