C4541003 C9 - Part B / DDI

Card Summary Component


This study is seeking healthy male and female participants of non-childbearing potential, meaning that the participants will not have the condition being studied.

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

  • Have a minimum body weight of 50 kg
  • Have body Mass Index of 17.5 - 28.5 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.



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.



The age a person must be to participate in a clinical trial.



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 determine if you qualify to enroll in the study.

Card Summary Component


The study is planned to last for approximately 11 weeks. There are several examinations procedures will be required in connection with the study:

  • A screening examination during which you will sign a COVID ICD and the study ICD.
  • A hospitalisation period of 14 days (13 nights)
  • A follow-up visit
  • 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.

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.

Required overnight stay

13 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.

How long is the study?

Approximately 11 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


Up to €2.945, plus travel 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.


Inhouse period from 02 to 16 May, 1 follow-up visit and 1 phone call

A detailed schedule will be handed over at screening.




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