This study is seeking healthy female participants.
Women of non-childbearing potential:
You may participate in this study provided that:
• You are between 18 and 45, and
• You have been surgically sterilised (hysterectomy with bilateral oophorectomy or bilateral tubal ligation).
• 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 following conditions:
- You have a non-hormonal IUD
- 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.
These non-hormonal contraceptive methods will have to be started at least 14 days before the start of the study and will have to be continued until Day 150 of the study.
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, smoker
- 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.
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 6 months.
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;
• 1 treatment visit on Day 1 and 21 ambulatory visits on Day 2, 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 127 and 141.
• The follow up visit will take place on Day 150.
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.
a follow-up visit at the end of the study
€ 2.285 upon completion of the study, + transportation fees (can be reimbursed after each visit)
Interested in participating?