Clinical Study: 36024

If you are a healthy male or female aged between 18 and 65, then you may be eligible to participate in a study investigating a new drug being developed for the treatment of a skin condition called atopic dermatitis (AD).

Study Payment* £1,925 – £5,300.

Apply for this study

*Terms & Conditions apply.

Study Payment: £1,925 – £5,300

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By agreeing to this form and selecting the box as outlined on your application, you are confirming that you have read the information provided in our data protection and consent policy, and give your consent for Simbec-Orion to record and retain your personal and special categories of data for the purposes and duration(s) stated above.

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 three-part study to investigate the study drug, SYX-5219.

The objectives of this study are to determine the safety, tolerability and levels of SYX-5219 in the blood and urine when SYX-5219 is given in different conditions e.g., following administration of different dose strengths, single and multiple doses, in the presence and absence of food and in the intended patient population. As well as evaluating the above, the study will also investigate and explore the effect of SYX-5219 on certain aspects of ECG (electrocardiogram) parameters, and the effect on the levels of cholesterol.

SYX-5219 is being developed as a potential treatment for a condition known as atopic dermatitis (AD); a skin condition often referred to as eczema which causes inflammation, redness and irritation of the skin. Currently, there are limited treatment options available for this condition (particularly for moderate to severe AD) which are considered long term and effective and there are no known cures. Therefore, there is an unmet need to develop potential new treatments which could be more effective.

This study will be split into three separate parts (Part 1, Part 2 and Part 3), and you will only participate in one part of the study (Part 1 and Part 2 for healthy volunteers only).

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Part 1 Standard Group

The purpose of Part 1 is to evaluate the study objectives when SYX-5219 is administered as a single dose at increasing dose strengths.

Part 1 will consist of up to 8 groups of up to 8 participants: each group will evaluate a different dose of SYX-5219 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 SYX-5219 or a placebo (which contains no active drug) in the form of oral capsule(s) 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 maximum period of 5 days (4 overnight stays) per treatment period followed by two return visits on Day 5 & Day 6 of each treatment period and a follow-up visit approximately 10 days following the last dose on Day 1.

You should also note that the timing of certain visits during the study i.e., the return visits on Day 5 & Day 6 and the post-study follow up visit may be extended/modified for all groups, or an additional return visit may be added (apart from Group 1) 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 when these visits will take place). Regardless of which group you are participating in, you should ensure that you are able to commit to completing all visits before agreeing to participate in this study and have sufficient flexibility to accommodate any revisions in the return visit/post-study follow up visit schedule.

If you are participating in the standard groups within Part 1 i.e., only completing one treatment period and you complete this part of the study, you will receive a maximum inconvenience payment of £1925.

Screening Visit
Day -35 to Day -2

Treatment Period
Day -1 to 4

Return Visits
Day 5 & Day 6

Post Study Follow Up Visit
Day 11

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Part 1 Food Effect Group

The purpose of Part 1 is to evaluate the study objectives when SYX-5219 is administered as a single dose at increasing dose strengths.

In addition, one group in Part 1 will investigate the effect of food on SYX-5219 by comparing the effects after taking a single dose of SYX-5219 following an overnight fast with the effects when SYX-5219 is given after eating a high fat meal.

If you participate in this part of the study and are in the food effect group i.e., completing two treatment periods, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 5 days (4 overnight stays) per treatment period followed by two return visits on Day 5 & Day 6 of each treatment period and a follow-up visit approximately 10 days following the last dose on Day 1 of treatment period 2. Each dose in each treatment period will be separated by a minimum period of 10 days; however, this period may be longer so you will be informed during the course of the study as to whether you are participating in this group and in addition, when you will need to return to complete the second treatment period.

You should also note that the timing of certain visits during the study i.e., the return visits on Day 5 & Day 6 and the post-study follow up visit may be extended/modified for all groups, or an additional return visit may be added (apart from Group 1) 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 when these visits will take place). Regardless of which group you are participating in, you should ensure that you are able to commit to completing all visits before agreeing to participate in this study and have sufficient flexibility to accommodate any revisions in the return visit/post-study follow up visit schedule.

If you are in the food effect group i.e., completing two treatment periods and you complete this part of the study, you will receive a maximum inconvenience payment of £3525.

Screening Visit
Day -35 to Day -2

Treatment Period 1
Day -1 to 4

Return Visits
Day 5 & Day 6

Washout Period
minimum of 10 days

Treatment Period 2
Day -1 to 4

Return Visits
Day 5 & Day 6

Post Study Follow Up Visit
Day 11

Apply Now. Be Amazing

Part 2

The purpose of Part 2 is to evaluate the study objectives when SYX-5219 is administered as multiple doses (currently planned as once daily) for a period of up to 14 days at increasing dose strengths.

Part 2 will consist of up to 5 planned groups of up to 8 participants: each group will evaluate a different dose of SYX-5219 based upon doses which have been evaluated in Part 1 of the study (where single doses at different dose strengths were given). This is known as a multiple ascending dose (MAD) study. Each group will receive SYX-5219 or a placebo (which contains no active drug) in the form of oral capsule(s) 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 maximum period of 17 days (16 overnight stays) followed by two return visits on Day 18 & Day 19 and a post study follow-up visit approximately 14 days following the last dose of SYX-5219 on Day 28.

You should also note that the timing of certain visits during the study i.e., the return visits on Day 18 & Day 19 and the post-study follow up visit may be extended/modified for all groups, or an additional return visit may be added 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 these visits will take place). Therefore, you should ensure that you are able to commit to completing all visits before agreeing to participate in this study and have sufficient flexibility to accommodate any revisions in the return visit/post-study follow up visit schedule.

If you complete this part of the study, you will receive a maximum inconvenience payment of £5300.

Screening Visit
Day -35 to Day -2

Treatment Period
Days -1 to 16

Return Visits
Day 18 & Day 19

Post Study Follow Up Visit
Day 28

Apply Now. Be Amazing

If you are a healthy male or female aged between 18 and 65, then you may be eligible to participate in a study investigating a new drug being developed for the treatment of a skin condition called atopic dermatitis (AD).

Study Payment* £1,925 – £5,300.

Your details

Study Information

Let's get started