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DISCOVER A NEW WAY TO HELP

If you are a healthy male or female (of non-childbearing potential) aged between 18 and 55, then you may be eligible to participate in a clinical trial investigating a treatment being developed for Dementia.

Inconvenience Payment of £3700. (Plus additional travel expenses)

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CLINICAL TRIAL information

Simbec-Orion Clinical Pharmacology is currently running to investigate a study drug, DNL593.

DNL593 is being developed for the treatment of a condition called frontotemporal dementia (FTD). 

This type of dementia is the most common form of dementia in people under 60 years of age and is a long-term progressive condition of the nervous system whereby there is an accumulation of proteins in certain cells in the brain, leading to death of these cells. 

Currently there are no effective treatments for FTD which can cure or slow down the progression of the disease; only treatments which aim to control some of the symptoms. Therefore, there is an unmet need to develop treatments which may be more effective in managing FTD such as DNL593 which is being evaluated in this study

The main objectives of the first part of this study (Part A) are as follows:

  • To determine the safety and tolerability of DNL593 when it is administered as a single dose on one occasion at different dose strengths and by different routes of administration.
  • To investigate the concentration of DNL593 in the blood, how this changes over a period of time.
  • To investigate the concentration of DNL593 in the fluid surrounding the brain and spinal cord, and to evaluate whether there are differences in the concentration between different dose strengths of DNL593 and between different routes of administration.

We will also investigate, as exploratory objectives, the effect of DNL593 on the body by analysing the levels of certain biomarkers in the body and will evaluate the immune system response to DNL593 through the measurement of anti-drug antibodies.

Part A will consist of 8 planned groups of 8 healthy volunteer participants: each group investigating a different dose strength starting at the lowest dose and gradually increasing in each group. 

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 5 days (4 overnight stays) for the initial treatment period, then return for four outpatient return visits (separated by approximately 7 days each) up to Day 28 and then attend a final post study follow-up visit after the dose of DNL593 (Day 84).

 Blood samples will be taken at set time points throughout this part of the study in order to measure the amount of DNL593 in the blood and the CSF. We will compare the results from each of the groups to determine if there are any significant differences in the profile of DNL593, amount of DNL593 in the blood and CSF, how this changes over time.

The purpose of the data generated in this study is to provide further information and guidance to support the study sponsor in the development of the study drug DNL593. 

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CLINICAL TRIAL timeline

If you complete this study, you will receive a maximum inconvenience payment of £3700. 

This payment is split into 5 parts: £750 after completion of the Day 7 visit, £250 after completion of the Day 14 visit, £250 after completion of the Day 21 visit, £500 after completion of the Day 28 visit and the remaining £1950 after completion of the Day 84 visit.

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 18-55 to participate in this trial. 

Your BMI must fall within the range of 18.0 – 32.0kg/m2 and have a minimum weight of 60kg to participate in this trial. 

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 any type of autoimmune disease?(e.g., lupus, psoriasis, Coeliac Disease, Crohn’s Disease, Type 1 diabetes)?
8. Do you have a history of any conditions of the brain, including history of stroke, cognitive impairment, seizures within the last 5 years, or head injury with loss of consciousness within the last 2 years?
9. Do you have a history of any serious back injuries, diseases of the spine or back surgery?
10. Have you been diagnosed with any significant psychiatric illnesses or experienced suicidal thoughts in the last 6 months?
11. Have you taken part in a clinical trial of an un-marketed or marketed drug in the last 90 days?
12. Have you ever suffered from a serious allergic reaction or have a known severe allergy including any allergies to anaesthetics?
13. Do you smoke or use any nicotine products (including vapes and eCigarettes)?
13a. Have you smoked or used any nicotine products within the last 3 months?
14. Have you donated more than 500 mL of blood in the last 56 days?
15. Do you drink alcohol?
15a. Do you consume more than 14 units per week? (For example, a can of beer/cider/lager is approximately 2 units)
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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