Apply for Clinical Clinical Study: 35832 // Payment £1275 to £2825

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We are running a five-part clinical study to investigate a drug called KH-001. If you are a healthy male and aged between 18 and 64, then you may be eligible to participate in a study investigating this new drug.

Study Payment* £2225 to £3225.

Apply for this study

*Terms & Conditions apply.

Study Payment: £2225 to £3225

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Please confirm that you have read these terms and understand that Simbec-Orion will be holding and processing your personal and special categories of data for the purposes stated above.

Simbec-Orion are also required to process your bio-metric data (a photograph only when you attend an onsite screening visit), we do this to ensure we can identify you for security purposes. We do not share this data with any other third-party, we solely use this data for the purpose of recognition. For the completion of your enrolment and part of your eligibility, we are required to collect this data. By selecting the box below, you also explicitly consent to the use of your bio-metric data as and when it is collected.

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Thank you for your time and interest, but unfortunately based on your answer, you are not eligible to apply for this study.

please check out our other studies to see if you may be eligible to apply for one of those.

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Study 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.

Blood and urine samples will be taken at set time points throughout each part of the study in order to measure the amount of KH-001 in the blood and urine (as applicable). In the context of the whole study, we will analyse the results from each of the groups and each study part and combine this information in order to better understand how KH-001 works.

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.

In the context of the whole study, we will analyse the results from each of the groups and each study part 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. 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).

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Part D

The purpose of Part D is to investigate the effect of changing the form in which KH-001 is administered on the safety, tolerability and concentration of KH-001 in the body, by taking a single dose of KH-001 following two treatment periods: one where KH-001 is administered in the form or an oral liquid (which has been administered in the previous parts of the study) and one where KH-001 is administered in a new formulation.

Part D will consist of one group of up to 8 participants who will investigate a new formulation using a dose strength of KH-001 which has already been evaluated in Part A of the study (where single doses at different dose strengths were given as an oral liquid). In Part D all participants will receive KH-001 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 up to three specific treatment periods (each comprising of two overnight stays per treatment period – Day -1 to Day 2), followed by a post-study follow up visit 5-7 days following the last dose of KH-001 in treatment period 2 or 3.

Following completion of each treatment period, the data will be reviewed, and a decision will be taken as to whether Treatment Period 3 is required and therefore, this treatment period is to be confirmed.

There will be approximately 7 days between each dose in each treatment period and each treatment period for this part of the study will require you to stay overnight at the clinical unit for 2 overnight stays.

Therefore, you should ensure that you are available to complete all required visits and overnight stays before agreeing to participate in the study

In addition, the timing of the post-study follow up visit may be extended from 5-7 days post-last 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).

Participants will receive a potential screening payment of £100

Maximum inconvenience payment of £3225

(If you complete two treatment periods in this part of the study, you will receive a maximum inconvenience payment of £2225 and if you complete three treatment periods in this part of the study, you will receive a maximum payment of £3225)

Plus up to £50 travel expenses for each required journey

Screening Visit

Treatment Period 1
Days: 3 (Day -1 to Day 2)

Treatment Period 2
Days: 3 (Day -1 to Day 2)

Treatment Period 3
Days: 3 (Day -1 to Day 2)

Post-Study Follow Up Visit
(Day 5-7 post last dose)

Clinical Study: 35832

We are running a five-part clinical study to investigate a drug called KH-001. If you are a healthy male and aged between 18 and 64, then you may be eligible to participate in a study investigating this new drug.

Study Payment* £2225 to £3225.

Your details

Study Information

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