誰が参加できますか

This study is seeking healthy male or female participants, meaning that the participants will not have the condition being studied. In addition to the criteria listed, participants must meet the following requirements:

  • Weight of 50 kg minimum
  • Body Mass Index of 17.5 - 30.5 kg/m2
  • Non-smoker, ex-smoker or smoker (max 5 cigarettes per day)
  • Able to meet all study visit requirements

There are other requirements for participation in this study. The study staff will explain these to you during the screening process.

 

FOR WOMEN ONLY:

Women of non-childbearing potential:

You may participate in this study provided that:

  • You are between 18 and 55 years old and
  • You are post-menopausal (meaning that your last period was at least one year ago)
  • OR ELSE you have been surgically sterilised (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy)
  • OR you have an ovarian failure

If you do not fall into one of these categories (described above), you will be considered as capable of having children. In this case, you will not be allowed to participate in this study.

Condition
Healthy
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Age
18-55
The age a person must be to participate in a clinical trial.
Sex
Male or female
The sex of people who may participate in a clinical trial. Sex is a person's classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can fully determine if you qualify to enroll in the study.

実施項目

The study is planned to last for up to 13 weeks.

Several examinations or procedures will be required in connection with the study:

  • A screening examination during which you will sign a COVID ICD and the study ICD.
  • 2 or 3 treatment periods, each organised of 8 days and 7 nights in the PCRU (from Day -1 to Day 7). The treatment periods will be separated by an interval of at least 14 days between the study medicine doses.
  • The follow-up phone call will take place 28-35 days after the last administration of the study medicine.

 

Required overnight stays
2 or 3 periods of 8 days and 7 nights
A participant may be required to stay overnight at the PCRU for observation and study procedures. The number and length of overnight stays is determined by the design of the study.
Long term follow up
Follow-up phone call
Some studies require the study team to stay in contact with the participant for a period of time after he or she completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.
How long is this study?
The study is planned to last for up to 13 weeks
The length of the study includes the time from screening until the final follow-up call or study activity. There may be up to 28 days between screening and dosing.
Compensation
€  4.469 for participation in the study + € 630 for COVID-19 prevention related inconveniences + transportation fees
Participants in clinical trials at the PCRU receive financial compensation for their participation. The amount depends on factors like length of the stay, total number of study visits, and the nature of the study procedures.

Interested in participating?

この治験についての詳しい情報:

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