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Duration of stay
This will involve a stay of 5 days / 4 nights and 7 follow-up visits to our clinical research unit
Ages
18-65
Location
London Bridge
Gender
Males & Females
Ethnicity
Any
Payment
£2,093
Smoking Restrictions
Smokers and non-smokers included
Trial Code
(C21038) Part A Cohort 3
Paid on completion of the study.
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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.
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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)

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If you would like to speak to a member of our Volunteer Recruitment Team, call us on 0800 085 6464
Register for this clinical trial

Contact our Volunteer Recruitment Team

Ref: (C21038) Part A Cohort 3 - (email_website_advert text)

Hear from some of our previous volunteers

“It’s like being part of a huge family gathering at Trials4us - even the cousin you don’t know very well goes out of their way to make you feel comfortable! Super professional as well as personable. 10/10”

Jonjo - November 2021

“Trials4us has been very informative and answered all of my questions and queries. The care has also been great, I have not had to worry, all the information has been very clear. They are very helpful and respond quickly”

Alex - June 2021

''I would like to thank Dr James Mitchell for always taking the time to answer any questions I have, no matter how small they are. He is very informed about my condition which is a novelty for me as my condition is very rare. His understanding has been a major influence in my participation of the trial''

James - December 2020

''I'm honestly very pleased with my experience with Trials4us. They were very helpful, and transparent about every step. I would definitely recommend them. 10/10 experience. Daniel and Omari, were especially nice and helpful. Thank you''

Mohamed - June 2020

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