Study 35751

If you are a healthy male or female aged between 18 and 55, then you may be eligible to participate in a trial investigating a new drug being developed for the potential treatment of viral infections including flu (influenza) and COVID-19

*Terms & Conditions apply.

Study Information

Simbec-Orion Clinical Pharmacology will soon be running a  three-part trial to investigate a drug called ETH47.

The overall objectives of this trial are to determine the safety, tolerability (degree to which side effects of a drug can be tolerated) and concentration in the blood of the trial drug when evaluated in different conditions i.e., single doses, different dose strengths and different routes of administration i.e., via a nasal route (intranasal), via an inhalation route (breathing in the drug) or via a combined intranasal/inhalation route. As well as evaluating the above, we will also investigate, as exploratory objectives, the effect of ETH47 on the body (known as pharmacodynamics) by analysing the levels of certain biomarkers in the body and will evaluate the immunogenicity (immune system response) to ETH47 through the measurement of antibodies. Biomarkers are markers within the body such as a gene, molecule or characteristic which can be used to identify the presence of a particular biological process occurring in the body or a particular disease. Antibodies are proteins which demonstrate if your immune system recognises certain parts of the drug.

Blood, nasosorption (a type of sample taken from the nose), nasal brushing and sputum samples will be taken at set time points throughout each part of the trial in order to measure the concentration of ETH47 and to measure for other markers as described above. In the context of the whole trial, we will analyse the results from each of the groups and each trial part and combine this information in order to better understand how ETH47 works in the body following assessment of different factors i.e., single doses, different dose strengths and different routes of administration i.e., via the nasal route (intranasal – Part A), via the inhalation route (breathing in the drug – Part B) or via a combined intranasal/inhalation route (Part C).

ETH47 is being developed as a potential treatment for infections caused by viruses that specifically affect the respiratory system (made up of the nose, mouth, throat and lungs) with a focus on initial development for treatments for flu (influenza) and COVID-19. Currently, there are some treatment options available for these conditions; however, these are limited in being very specific to the particular virus which causes the infection and are not often effective in severe forms of the infection. Therefore, there is an unmet need to develop more effective treatments that can be used more broadly as a single treatment, and which may be more effective in severe cases of the infections.

This trial will be split into three separate parts (Parts A, B & C), and you will only participate in one part of the trial and within each part, only participate within one group.

Part A

The purpose of Part A is to evaluate the trial objectives when ETH47 is given as a single dose on one occasion at different dose strengths and administered via a mist/spray into both nostrils (known as intranasal administration).

Part A will consist of 5 planned groups of up to 8 participants: each group will evaluate a different dose of ETH47 starting at the lowest dose and gradually increasing in each group. Each group will receive ETH47 or a placebo (which contains no active drug) in the form of a nasal mist/spray which will be administered directly into both nostrils via a nasal atomiser device (a syringe attached to a plug which delivers the drug as a fine mist into the nostril).

If you participate in this part of the trial, you will be required to stay at the Simbec-Orion clinical unit for a period of 6 days (5 overnight stays – Day -1 to Day 5) for the in-house period, followed by 2 single day return visits (Day 7 & Day 14) and an end of study visit approximately 3 weeks following the dose of ETH47 (Day 21). You should therefore ensure that you are able to commit to completing all visits before agreeing to participate in this trial.

You will be required to complete all three treatment periods which will be separated by 5-14 days between doses of MDI-26478 or placebo. Each treatment period 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..

If you complete this part of the study, you will receive a maximum inconvenience payment of £2850

Part B

The purpose of Part B is to evaluate the trial objectives when ETH47 is given as a single dose on one occasion at different dose strengths and administered via a mist/spray into the mouth to be breathed into the lungs (known as inhalation administration).

Part B will consist of 5 planned groups of up to 8 participants: each group will evaluate a different dose of ETH47 starting at the lowest dose and gradually increasing in each group. Each group will receive ETH47 or a placebo (which contains no active drug) in the form of a mist/spray which will be administered directly into the mouth via a syringe attached to a nebuliser device (a type of inhaler device which creates a fine mist that can be breathed directly into the mouth and lungs, similar to the types of devices given to patients suffering with an asthma attack).

If you participate in this part of the trial, you will be required to stay at the Simbec-Orion clinical unit for a period of 6 days (5 overnight stays – Day -1 to Day 5) for the in-house period, followed by 2 single day return visits (Day 7 & Day 14) and an end of study visit approximately 3 weeks following the dose of ETH47 (Day 21). You should therefore ensure that you are able to commit to completing all visits before agreeing to participate in this trial.

All of the visits from Day 7 onwards are single day visits i.e., you will not be required to stay overnight at the clinical unit. However, you should ensure that you are able to commit to all of the relevant dates for each visit and commit to the 5 overnight stays required as part of the in-house period (Day -1 to Day 5) as these visits are not flexible. Therefore, you should ensure that you are available to complete all required visits and overnight stays before agreeing to participate in the trial.

If you complete this part of the trial, you will receive a maximum inconvenience payment of £2600.

Study Payment: £2450 to £2850 Apply. Be amazing

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