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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 65, then you may be eligible to participate in a clinical trial investigating a new drug being developed for the treatment of autoimmune and inflammatory diseases.

Study Payment £4065 

Plus Travel Expenses.

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CLINICAL TRIAL information

Simbec-Orion Clinical Pharmacology will soon be running a two part study to investigate a drug called MB272.

The overall objectives of the study are to determine the safety, tolerability and concentration in the blood of the study drug when evaluated in different conditions i.e., different dose strengths, following administration of single and multiple doses, and following administration in two different forms. 

The study also aims to evaluate the effect of the study drug on the body, through the collection of blood samples at different times through the day.

The levels of the study drug in the blood will be measured at different times throughout the study in order to evaluate the study objectives. 

The study drug is being developed for the treatment of a range of different diseases which can be broadly categorised as autoimmune and inflammatory diseases.

This study will be split into 2 separate parts, (Part A and Part B) and you will only be able to participate in one part of the study.

We Have successfully enrolled 93 Volunteers on to this study to date.

The purpose of Part A is to evaluate the study objectives when MB272 is given as a single dose on one occasion at different dose strengths and by different routes of administration. 

Part A will consist of 7 planned groups of up to 8 participants per group: each investigating a different dose strength of MB272 starting at the lowest dose and gradually increasing in each group. 6 out of the 7 groups will receive MB272 or a placebo (which contains no active drug) intravenously  on once (Day 1) with 1 group receiving MB272 or a placebo subcutaneously once (Day 1).

 

Administration in a subcutaneous form will occur whilst the intravenous infusion groups are ongoing.

If you participate in this part of the study, you will be required to stay at the Simbec-Orion clinical unit for a period of 6 days (5 overnight stays – Day -1 to Day 5) for the treatment period, followed by 6 return day visits and a final post-study follow-up visit.

You should therefore ensure that you are able to commit to completing all visits before agreeing to participate in this study.

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CLINICAL TRIAL timeline

 

Cohort 9 Screening from: 19th September 2023

Cohort 9A:
Into Simbec: 16th October
Leave Simbec: 21st October
Return Visits: October 24th and 31st, November 7th, 14th and 28th, December 12th
Post Study Visit: January 9th 

 

Cohort 9B:
Into Simbec: 23rd October
Leave Simbec: 28th October
Return Visits: October 31st, November 7th, 14th and 21st, December 5th and 19th
Post Study Visit: January 16th 

 

Cohort 9C:
Into Simbec: 25th October
Leave Simbec: 30th October
Return Visits: November 2nd, 9th, 16th and 23rd, December, 7th and 21st
Post Study Visit: January 18th

Cohort 10 currently planned for screening in January 2024, dates to be confirmed soon. Applications still being accepted
in the meantime.

If you fully complete this study, you will receive a maximum inconvenience payment of £4065. 

 We also pay additional travel expenses for every visit up to a maximum of £50.

 

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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 18-65 to participate in this trial. 

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

Your BMI = [ Field74 / ( Field77 * Field77 ) ]

Have you previously participated in a trial at Simbec-Orion?
1. Do you regularly use substances that are used for non-medicinal and leisure purposes. We test as part of the screening assessments for all our trials?(A urine sample will be collected for drugs of abuse testing at screening (Alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids/tetrahydrocannabinoids (THC), cocaine, methadone, and opiates etc)
2. Have you been diagnosed or tested positive for Coronavirus/COVID-19 within the last month?
3. Have you received a COVID-19 vaccination or any vaccination in the last 60 days?
4. Are you registered with a UK GP Surgery/Practice (for at least 6-12 months) ?
5. Are you currently taking any prescription or repeat medication from a GP or a chemist within the last 28 days?
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 taken part in a clinical trial of an un-marketed drug in the last 90 days/3months?
9. Have you taken part in a clinical trial of a marketed drug in the last 30 days/1 month?
10. Have you ever suffered from a serious allergic reaction or have a known severe allergy?
11. Do you smoke or are you a current cigarette user?
11a. Do you or have you used any nicotine products (including, nicotine vapes, e-cigarettes and any nicotine replacement therapy) within the last 6 months?
12. Have you donated more than 450 mL of blood in the last 90days/3months?
13. Do you drink alcohol?
13a. Do you consume more than 14 units per week? (For example, a can of beer/cider/lager is approximately 2 units)
14. Have you had any body piercings or tattoos in the last 28 days?
15. . Do you have any dietary restrictions (i.e., vegan/vegetarian, medical, social, cultural or religious) which would prevent you from consuming standardised meals (including meat, gluten and dairy products) or from consuming gelatine?
16. Are you currently using some form of contraception (if you are a male or female of non-childbearing potential in a heterosexual relationship)?
16a. If “Yes” answered selected options available to select:
16b. If “No” 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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