This study is seeking healthy male & 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:
- 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.
FOR WOMEN ONLY:
Women of non-childbearing potential: You may participate in this study provided that:
• You are between 18 and 60 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
Women of childbearing potential: At each visit to the PCRU, we will check that you are using the appropriate contraception. You must fulfil one of the conditions below:
▪You have had a bilateral tubal occlusion
▪ You have a non-hormonal IUD
▪ You have a hormonal IUS
▪ You have a (progestogen-only) hormonal implant
▪ Your partner has undergone a vasectomy at least six months ago
▪ You are abstinent from heterosexual intercourse as your preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
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.
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 18 days (17 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.
Interested in participating?