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.

*Terms & Conditions apply.

Study Payment: £1275 to £2825

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).

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. .

In addition, 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.

Part B

The purpose of Part B is to evaluate the study objectives when KH-001 is given as a single dose once daily for a period of five days at different dose strengths.

Part B will consist of 2 planned groups of up to 9 participants (with the option to include a maximum of 2 additional groups with up to 9 participants each): each group will evaluate a different dose based on doses which have been evaluated in Part A of the study (where single doses at different dose strengths were given). 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 7 days (6 overnight stays – Day -1 to Day 6) 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.

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).

If you complete this part of the study, you will receive a maximum inconvenience payment of £2825.

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