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This study is seeking healthy male and 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:

For Women:

  • Be a woman of non-childbearing potential. This means that you are either post-menopausal or that you have been surgically sterilized.

OR

  • Be a woman of childbearing potential who fulfills one of the criteria listed below:
    • Have had a bilateral tubal occlusion
    • Have a non-hormonal IUD
    • Have a hormonal IUS
    • Have a partner who has undergone a vasectomy at least six months ago.

For Both Sexes:

  • Have a minimum body weight of 50 kg
  • Have body Mass Index of 25.0 - 40.0 kg/m2
  • Be a non-smoker or a smoker who smokes a maximum of 5 cigarettes per day
  • Be 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.

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 years
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.
もっと参加基準を表示する

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 approximately 10 weeks. There are several examinations procedures will be required in connection with the study:

  • A screening examination
  • A hospitalisation period of 7 days (6 nights)
  • A follow-up phone call

Each participant will have a follow-up phone call 28 to 35 days after administration of the last dose of study medicine.

Required Over Night Stays
2 treatment periods organised of 3 nights each in the Unit
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
1 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 the study?
Approximately 10 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
€ 1350 + € 180 additional COVID fees for participation, plus transportation expenses
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:

0800.99.256 (フリーダイヤル:ベルギーから)、00800.26.36.26.36(フリーダイヤル:イギリス、フランス、ドイツ、オランダから)、+32.25.66.78.46(有料ダイヤル:上記以外の国から)に電話し、担当者に詳細をお問い合わせください。または、以下の登録フォームに入力してご送信ください。

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