Clinical Study: 36200

If you are a male or female with a confirmed diagnosis of mild to moderate asthma 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 certain types of asthma.

*Terms & Conditions apply.

Study Payment: £8300

Study Information

Simbec-Orion Clinical Pharmacology will soon be running a two-part study to investigate the study drug, GB-0895.

The overall objectives of this study are to determine the safety, tolerability (degree to which side effects of a drug can be tolerated) and concentration in the blood of GB-0895 when GB-0895 is administered in different conditions i.e., single versus multiple doses and evaluating different dose strengths. Blood samples will be taken at set timepoints throughout each part of the study in order to measure the levels of GB-0895 and the levels of specific markers which are associated with the study drug and its’ intended effect. 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 GB-0895 works in the body following assessment of different factors within each study part i.e., single versus multiple doses and different dose strengths.

GB-0895 is being developed for the treatment of certain types of asthma which is a common condition of the lungs that can cause difficulties in breathing as a result of inflammation (swelling) in the breathing tubes which carry air in and out of the lungs. Currently, there are many different treatment options available for this condition, including medicines that work in a similar way to GB-0895; however the intention of GB-0895 is to provide a treatment which may be taken less frequently than other treatments but with the same level of effectiveness.

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

Part A

The purpose of Part A is to evaluate the study objectives when GB-0895 is administered as a single dose at increasing dose strengths.

Part A will consist of up to 5 planned groups of up to 10 participants with mild to moderate asthma in each group who will evaluate a different dose of GB-0895 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 GB-0895 or a placebo (which contains no active drug) in the form of subcutaneous injection(s) which is a type of injection(s) into the tissue layer between the skin and muscle.

For all groups in Part A, you will be required to stay at the clinical unit for a maximum of 4 overnight stays for the treatment period.

If you participate in this part of the study, you will be required to stay at the Simbec-Orion clinical unit for 5 days (4 overnight stays – Day -1 to Day 4).

There are 12 return/outpatient visits (Days 5, 8, 15, 29, 60, 90, 120, 150, 180, 210, 270, 360), a telephone call assessment on Day 450, followed by a post-study follow up visit on Day 500. Therefore, you should ensure that you are able to commit to completing all visits before agreeing to participate in this study.

Each return visit will not require you to stay overnight; these visits will be day visits and will take less than a couple of hours to complete. You should ensure that you are available to complete all required visits before agreeing to participate in the study

If you complete this part of the study, you will receive a maximum inconvenience payment of £8300. This payment will be split into 7 parts as follows: £1000 after completion of the Day 8 visit, £1000 after completion of the Day 29 visit, £1000 after completion of the Day 90 visit, £1000 after completion of the Day 180 visit, £1000 after completion of the Day 270 visit, £1000 after completion of the Day 360 visit and a final payment of £2300 after completion of the Day 500 visit.

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You must be registered with us to participate in our clinical studies. Simply complete the online application, it takes around 4 minutes and 33 seconds to become a volunteer.

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