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DISCOVER A NEW WAY TO HELP

If you are a healthy male aged between 18 and 64, then you may be eligible to participate in a study investigating a new drug being developed for the potential treatment of premature ejaculation.

Study Payment £1275

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CLINICAL TRIAL information

Simbec-Orion Clinical Pharmacology will soon be running a five-part study to investigate a drug called KH-001.

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

The study also aims to evaluate the effect of the study drug on the body, particularly assessing the effect of the drug on overall mood state. 

We will analyse the results from each of the study groups/parts and combine this information in order to better understand how KH-001 works in the body following assessment of different factors within each study part i.e., single and multiple doses, different dose strengths, different dose forms, in the presence and absence of food and comparing between a plant-based (botanical) and man-made (synthetic) version of the drug.

KH-001 is being developed as a potential treatment for a condition known as premature ejaculation (a condition characterised by ejaculation within 1-2 minutes of initiating sexual intercourse).

Currently, there are limited treatment options available for this condition with
treatments often associated with side effects. Therefore, there is an unmet
need to develop more effective treatments that can be used long-term with
reduced side effects.

This study will be split into five separate parts, and you will only participate in
one part of the study (with the exception of participants in Groups 1-3 of Part
A who may be invited to also take part in Part C).


WE ARE CURRENTLY RECRUITING PART A ONLY.

PART A

The purpose of Part A is to evaluate the study objectives when KH-001 is given as a single dose on one occasion at different dose strengths.

Part A will consist of 4 planned groups of up to 8 participants (with the option to include a maximum of 2 additional groups with up to 8 participants each).

Each group will evaluate a different dose of KH-001 starting at the lowest dose and gradually increasing in each group. This is known as a single ascending dose (SAD) study.

Each group will receive KH-001 or a placebo (which contains no active drug) in the form of an oral liquid which participants will swallow.

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 3 days (2 overnight stays – Day -1 to Day 2) for the treatment period, followed by a post-study follow-up visit 5-7 days following the last dose of KH-001.

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

You should also note that the timing of the post-study follow up visit may be extended from 5-7 days post-dose if the data generated during the study indicates that it is necessary to do so (you will be informed as to whether this is the case and subsequently when the post-study follow up visit will take place).

If you complete this part of the study, you will receive a maximum inconvenience payment of £1275, plus travel expenses. 

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CLINICAL TRIAL timeline

Part A Study Dates

You will only take part in one group within Part A of the study; however, if you participate in Groups 1-3 of Part A, you may also be eligible to participate in Part C (Food Effect). If this is the case, and you wish to participate in Part C, you will be required to complete, sign and date a new participant information sheet and consent form which is specific to Part C at the time you participate.

Cohort 1: FULLY BOOKED

Cohort 2: FULLY BOOKED

Cohort 3a:
Screening From: 9th January
Into Simbec: 5th February
Leave Simbec: 7th February
Follow-Up Visit: 12th February

Cohort 3b:
Screening between: 11th January
Into Simbec: 7th February
Leave Simbec: 9th February
Follow-Up Visit: 13th February 

 

If you complete Part A of this study, you will receive a maximum inconvenience payment of £1275.
We additionally pay travel expenses up to a maximum of £50 per journey required to Simbec.

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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 18-64 to participate in this trial. 

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

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

1. Have you previously screened for a trial at Simbec-Orion?If you have previously screened for a trial, you will likely be registered on our database. Please alternatively contact enrolmentservices@simbecorion.com to express interest.
2. 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 during both screening and the trial)
3. Have you received a COVID-19 vaccination?
4. Are you registered with a UK GP Surgery/Practice?You must be a UK resident for at least one 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 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?
10. Have you ever suffered from a serious allergic reaction or have a known severe allergy?
11. Do you smoke or use any nicotine products?This includes vapes and e-Cigarettes
11a. Have you used any of these products in the last 6 months?
11b. Have you used any type of smoking cessation medication in the last 6 months?I.e., gums, patches etc.
12. Do you have any dietary restrictions which would prevent you from consuming a standardised high-fat meal, which includes meat, gluten and dairy products?Dietary restrictions such as vegan, vegetarian, medical, social, cultural or religious restrictions
13. Have you donated more than 450 mL of blood in the last 90days/3months?
14. Do you drink alcohol?
14a. Do you consume more than 14 units per week?For example, a can of beer/cider/lager is approximately 2 units
15. Have you had any body piercings or tattoos in the last 28 days?
16. Are you currently using some form of contraception (if you are a male in a heterosexual relationship)?
16a. If “Yes” answered selected options available to select:
16b. If you are currently not using any contraception and are a male of childbearing potential in a heterosexual relationship, would you be willing to use a condom from the point of first dose until 3 months after the last dose (total duration of approximately 4-6 months) in order to participate in the study?

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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