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DISCOVER A NEW WAY TO HELP

If you are a healthy male aged between 18 and 50, then you may be eligible to participate in a clinical trial investigating a treatment being developed for a range of different diseases known as autoimmune diseases.

Study Payment ranging from £4290 – £5090.

Plus Travel Expenses

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study information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate a new drug called AX-158.

AX-158 is being developed for the treatment of a range of different diseases which can be broadly categorised as autoimmune and inflammatory diseases. AX-158 is specifically being developed to treat autoimmune and inflammatory diseases such as psoriasis, multiple sclerosis (MS), rheumatoid arthritis and Crohn’s disease.

Currently, there are treatment options available for these conditions; however, these treatments tend to act by blocking the activity of the whole immune system (immunosuppressants) which can leave individuals open to developing infections easily and therefore, there is an unmet need to develop potential new treatments which could be more effective.

The main objectives of this study are as follows:

  • To determine the safety and tolerability  of AX-158 when it is administered as single and multiple doses at different dose strengths over a period of up to 10 days.
  • To investigate the concentration of AX-158 in the blood and urine, how this changes over a period of time and to evaluate whether there are differences in the concentration between different dose strengths over time and between single or multiple doses.
  • To investigate the effect of food on the concentration of AX-158 in the blood following administration of AX-158 in both a fasted state (without food) and fed state (following a high-fat breakfast).

This study will be split into 3 separate parts: Part A, B & C. Part A & B is fully recruited. WE ARE NOW RECRUITING FOR PART C

PART C 

The purpose of Part C is to evaluate the safety, tolerability and concentration of AX-158 in the blood and urine when it is given as a single dose once a day for a period of 10 days  (this may be increased to 14 days following Part A data review) at different dose strengths. Part C will consist of 3 planned groups of up to 8 participants in each group: each investigating a different dose strength starting at the lowest dose and gradually increasing in each grou

 

 

If you participate in this part of the study, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 14 days, 13 overnight stays, (this may be increased up to 18 days, 17 overnight stays, following Part A data review) followed by a post study follow-up visit approximately 7 days after the last dose of study drug and you should therefore ensure that you are able to commit to completing all visits before agreeing to participate in the study.

 

 

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study timeline

Part C

 If you complete this part of the study, you will receive a maximum inconvenience payment of £4290
[INCREASE PAYMENT TO £5090 IF DOSING DURATION EXTENDED TO
MAXIMUM 14 DAY PERIOD]. 

We also pay additional travel expenses for every visit.

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Thank you for your time to register your interest in this trial please complete the below form.

OR to speak to a member of the Enrolment Team for more information or regarding any questions or queries please ring 0800 691995 and please select option 1. Alternatively drop us an email: enrolmentservices@simbecorion.com 

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1 Step 1

To enable us to make an assessment of your suitability for a Clinical Trial, we will first need to gather some personal details relating to your health. To ensure your suitability for a Clinical Trial, by ticking the checkbox you agree that the information you have provided is accurate to the best of your ability. Your personal data will be stored on our database which is only accessible by Simbec Research Ltd and our service providers. To aid in your suitability assessment, we will only share with companies that support us delivering our services. Under the current European Data Protection Laws (GDPR), you have a number of rights in relation to your personal data such as the right to access, right to rectification and right to be forgotten where appropriate. Please note: if you have not been contacted within 3 months of applying for a trial, please assume you are ineligible and that your data has been deleted from our system, if you believe you are eligible for another one of our trials, please apply again in 3 months.

For more information regarding our commitment to your privacy, please read our privacy policy.

Agreement

You must be between the age of 18-50 to participate in this trial. 

Your BMI must fall within the range of 18.0 – 30.0kg/m2. 

Your BMI = [ Field17 / ( Field53 * Field53 ) ]

1. Do you regularly use illegal drugs?(i.e. Substances that are used for non-medicinal and leisure purposes. We test as part of the medical.)
2. Have you been diagnosed or tested positive for Coronavirus/COVID-19 within the last month?
3. Have you received a COVID-19 vaccination in the last 28 days?
4. Are you registered with a GP?(must be a UK resident for at least 1 year)
5. Are you taking any prescription or repeat medication from a GP or a chemist (including any over-the-counter medications, vitamins or supplements)?
6. Do you suffer from or ever had any serious illnesses as diagnosed by your GP or health professional? (e.g. neurological, endocrinal, cardiovascular, pulmonary, haematological, immunologic, psychiatric, gastrointestinal, renal, hepatic and metabolic disease)?
7. Do you suffer from/have a history of gastro-intestinal conditions or surgeries?
8. Have you suffered from a serious infection in the last 3 months?
9. Have you taken part in a clinical trial of an un-marketed drug in the last 3 months?
10. Have you taken part in a clinical trial of a marketed drug in the last 30 days?
11. Have you ever suffered from a serious allergic reaction or have a known severe allergy?
12. Do you smoke or use any nicotine products (including vapes and eCigarettes)?
12a. Have you smoked or used any nicotine products within the last 6 months?
13. Have you donated more than 500 mL of blood in the last 3 months?
14. Do you drink alcohol?
14a. Do you consume more than 21 units (for males) or 14 units (for females) per week? (For example, a can of beer/cider/lager is approximately 2 units)
15. FOR PART B & C ONLY, IF PART A APPLICANT PLEASE SELECT OPTION 3 - Are you vegan or vegetarian or have any social, religious or cultural reasons which would prevent you from eating a high fat or standardised breakfast (high fat breakfast includes eggs, bacon, whole milk)?
16. Have you had any body piercings or tattoos in the last 3 months?
17. Are you currently using some form of contraception (unless you are a female of non-childbearing potential, single with no current sexual partners or in an exclusively homosexual relationship)?
17a. If “Yes” answered selected options available to select:

Thank you for your time and interest, but unfortunately based on your answer, you would be unable to participate in this trial at this time. But please feel free to fill out a general application form or keep a lookout for other clinical trials we may be recruiting for, as you may be eligible to help in a different trial

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