Clinical trial summary
We are conducting a clinical trial for an investigational medicine that could be used to treat people with Respiratory Syncytial Virus which causes severe chest infections in infants and the elderly.
In this clinical trial, we are asking up to 96 Caucasian and 8 Japanese healthy male and female participants aged 20 to 40 to take part in a trial for an investigational medicine, so we can see how your body deals with the investigational medicine and how long the investigational medicine stays in your body.
If you are interested in participating in the trial:
- You will need to attend a screening appointment so we can check if you are suitable to take part in the trial. At this appointment we will take blood samples, check your heart, and carry out a physical examination.
- You will be required to wear a heart monitor for 24 hours after the screening appointment and will need to return it to the unit.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part.
- This will involve a stay of 5 days / 4 nights in our clinical research unit.
- After your stay with us, you will be required to return for further appointments on Day 4, Day 5, and Day 8 of the trial.
- In total, if you are included in the clinical trial you will come to the research unit 5 times.
- During your stay with us, you will receive a single dose of the investigational medicine via your mouth and we will conduct a number of assessments (like those we did at screening) to check how well you tolerate the investigational medicine, and to help us understand how long it takes for your body to get rid of the investigational medicine.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:
- You are a healthy Caucasian male or female aged 20 to 40 years of age.
- Your Body Mass Index is between 18.0-25.0 kg/m2.
- You must be healthy with no underlying medical conditions that may affect the trial or put you at any significant risk.
- You must be able to consume all meals as part of a standardised diet, including meat, dairy, and gluten.
- Female participants of childbearing potential, if heterosexually active, must agree to the use of highly effective contraception starting from one complete menstrual cycle prior to the first dose until at least 5 weeks after the last dose.
- Male participants must be willing to use appropriate barrier contraception starting from the first dose for at least 13 weeks after last dose, with female partners of child-bearing potential, including partners that are already pregnant.
- You must not donate sperm or ova (eggs) from the time of the first study drug administration until three months after the last follow-up visit.
- You must not test positive for alcohol or drugs at screening or admission, or show any evidence of alcohol or drug abuse within the last two years.
- You must not have used tobacco (e.g., smoking, patch, electronic cigarettes) within three months of the first dose of the study drug.
- You must not have taken part in another clinical trial in the last three months.
- You must not use any prescription drugs within 14 days or over-the-counter drugs within 7 days of the first dose of the study drug.
- You must not have a history of severe allergic reactions to any product.
Clinical trial payment
In recognition of the time involved in taking part in the trial, you will receive £2,094 (£1,398 clinical trial payment and £698 bonus) on completion of the clinical trial, provided you comply fully with all the clinical trial requirements. This amount is based on the anticipated clinical trial plan and will be adjusted pro-rata (i.e. same amount of money paid per unit of time), should we invite you to attend extra visits.
Clinical trial dates
(Participates will only be selected for one cohort).
In-house period: 15 - 19 December
Follow-up appointment(s): 20, 21 & 24 December
In-house period: 18 - 22 December
Follow-up appointment(s): 23, 24 & 29 December
You may be required to remain resident in the unit until the resolution of any safety issues, after which you will be discharged from the unit.
The contents of this page have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.