Clinical trial summary
We are conducting a clinical trial for a new medicine that could be used to treat people with gout. For Part A of this clinical trial we are recruiting 113 healthy male and female participants aged 18 to 65. We will observe how your body processes 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 will take blood, check your heart and carryout a physical examination.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part.
o This will involve a stay of 5 days /4 nights in our clinical research unit.
o After your stay with us you will be required to return for further appointments on Day 15, Day 29, Day 43, Day 57 and Day 85 of the trial. In addition, you will be required to return to the clinic for follow-up visits three months and six months after Day 85 of the trial. This means the whole process takes approximately 10 months from your screening visit through to your final visit.
o In total, if you are included in the clinical trial you will come to the research unit approximately 11-12 times.
- During your stay with us you will receive a single dose of the new medicine subcutaneously (i.e. injection just under the skin) 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 process the new medicine.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You are a male or female aged between 18 to 65.
- You have a Body Mass Index (BMI)within the range of 18.0 and 28.0 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 not test positive for alcohol or show any evidence of alcohol abuse for 12 months prior to dosing.
- You must not test positive for drugs or show any evidence of drug abuse 12 months prior to dosing.
- You must not use prescription drugs within 14 days prior to screening.
- Female participants of childbearing potential, if heterosexually active, must agree to the use of highly effective contraception starting at least one complete menstrual cycle before the first dose until all safety follow-up visits (if applicable) are completed.
- Male participants, if heterosexually active, must agree to the use of acceptable contraception starting from first dose until all safety follow-up visits (if applicable) are completed.
- Female participants must not be pregnant or breastfeeding.
- You must not have history of gout.
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 £2,093 (£1,403 clinical trial payment and £690 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 date: 14th June to 18th June
Follow-up visit: 30th June, 14th July, 28th July, 11th August, 8th September, 1st December and 23rd February 2023
The contents of this email 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.
You may be required to remain resident in the unit until resolution of any safety issues, after which you will be discharged from the unit.
Ref: C21.038_DEC-2021 (email_website_advert text)