Duration of stay
We are conducting a clinical trial for a new medicine that could be used to treat people with diseases involving dysregulation of part of the immune system which is needed for the body to fight infections.
Clinical trial summary
In this clinical trial, we are asking up to 8 healthy Japanese male and female participants and 16 healthy non-Japanese male and female participants aged 18 to 45 to take part in a trial for a potential new medicine. We will see how your body deals with the new medicine and how long the new 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 perform a number of tests including, taking blood samples for safety tests, checking your heart and carrying out a physical examination to see if you will be OK to take part in the clinical trial. You may also be required to have vaccinations against N. meningitidis (a bacteria that causes meningitis) and take antibiotics until approximately Day 155 of the trial.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part.
- This will involve:
- two stays of 6 days / 5 nights
- one stay of 3 days/2 nights in our clinical research unit.
- After your stay with us you will be required to return for 13 short appointments up to the end of the trial.
- During your stay with us you will receive three doses of the new medicine subcutaneously (i.e. using a small needle under the skin of your abdomen) and we will conduct a number of assessments (like those we did at screening) to check how well you tolerate the new medicine, and to help us understand how long it takes for your body to get rid of the new medicine.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You are a healthy male or female aged 18 to 45 years of age.
- You must have a bodyweight of 50 to 100 kg and your Body Mass Index (BMI) is between 17 and 32 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 not test positive for alcohol or show any evidence of alcohol abuse.
- You must not test positive for drugs or show any evidence of drug abuse.
- You must not use prescription drugs within 7 days prior to the first investigational medicine administration.
- Females must not have donated or lost blood within 16 weeks prior to first dosing.
- Females must not be pregnant or breastfeeding.
- 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 months after the last dose.
- Male participants must be willing to use appropriate barrier contraception starting from screening for at least 5 months after last dose, with female partners of child-bearing potential, including partners that are already pregnant.
- You must not use tobacco in any form (e.g., smoking or chewing) or nicotine products in any form (e.g., gum, patch, electronic cigarettes) within 24 hours of the planned first dosing day.
A full list of do’s and don’ts will be given to you by a member of our recruitment team if you are interested and want to find out more.
Clinical trial payment
In recognition of the time involved in taking part in the trial, you will receive £3,116 (£2,181 clinical trial payment and £935 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
Admission 1: 22-Mar-22 to 27-Mar-22
Admission 2: 29-Mar-22 to 31-Mar-22
Admission 3: 05-Apr-22 to 10-Apr-22
13-Apr-22, 20-Apr-22, 27-Apr-22
04-May-22, 11-May-22, 18-May-22
01-Jun-22, 15-Jun-22, 29-Jun-22
13-Jul-22, 27-Jul-22, 10-Aug-22
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.