Study 35736

If you are a healthy male or female aged between 18 and 60, then you may be eligible to participate in a study investigating a new drug being developed for the potential treatment of severe allergic reactions.

*Terms & Conditions apply.

Study Information

Simbec-Orion Clinical Pharmacology will soon be running a three-part study to investigate the study drug, ADD008 (active ingredient adrenaline, herein referred to as epinephrine as this is the applied term for the synthetic (man-made) form of adrenaline).

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 epinephrine when evaluated in different conditions i.e., single and repeat doses, different dose strengths and in different forms i.e., in the form of a sublingual tablet (which dissolves under the tongue – test drug ADD008) in comparison with EpiPen® (a marketed form of injectable epinephrine used in the treatment of severe allergic reactions). The purpose of the overall study is to determine as to which dose strength of ADD008 demonstrates the most comparable concentrations in the blood to the standard dose of the current recommended standard treatment for allergic reactions (EpiPen®).

Blood samples will be taken at set timepoints throughout each part of the study in order to measure the levels of ADD008 and EpiPen® in the blood. We will compare the results between each treatment period and each study part to determine if there are any significant differences in the safety of epinephrine, the concentration of epinephrine in the blood and how this concentration changes over time or when epinephrine is administered in different conditions i.e., single and repeat doses, different dose strengths and in different forms i.e., in the form of a sublingual tablet (which dissolves under the tongue – test drug ADD008) in comparison with EpiPen® (a marketed form of injectable epinephrine).

ADD008 is being developed for the treatment of severe allergic reactions. Currently, there are multiple injectable forms of epinephrine available which are used in the treatment of severe allergic reactions including systems such as EpiPen®; however, these are not always the easiest of products to use and are often expensive so are not accessible to all individuals who may require this type of product to manage their condition. Therefore, there is an unmet need to develop potential new formulations of epinephrine which could be more effective and reduce these challenges.

This study will be split into three separate parts (Parts 1, 2a & 2b), and you will only participate in one part of the study.

Part 1

The purpose of Part 1 is to evaluate the study objectives when ADD008 is administered as a single dose at increasing dose strengths, in comparison with a single dose of EpiPen®.

Part 1 will consist of 10 participants with participants receiving ADD008 and EpiPen® across 6 treatment periods. For the first treatment period, all participants will receive a 0.3 milligram (mg) dose of EpiPen® and for the remaining 5 treatment periods, all participants will receive increasing doses of ADD008 ranging from 2 mg up to 30 mg. There will be a minimum of 24 hours between each dose in each treatment period.

If you participate in this part of the study, you will be required to stay at the Simbec-Orion clinical unit for the following visits. Due to the way that the study is scheduled in the clinical unit, the treatment periods will be split into two parts (treatment periods 1-3 and treatment periods 4-6).

This means that you will be required to stay at the clinical unit for the following overnight stays:

  • Treatment Periods 1-3 – total of 4 days with 3 overnight stays
  • Treatment Periods 4-6 – total of 4 days with 3 overnight stays (to be completed approximately 3 days after discharge from the clinical unit in treatment period 3)

A post-study follow-up visit will be completed approximately 2-5 days following the last dose in treatment period 6. You should therefore ensure that you are able to commit to completing all visits before agreeing to participate in this study. If you complete this part of the study, you will receive a maximum inconvenience payment of £3050.

There will be a minimum of 24 hours between the doses in each treatment period and due to the way that the study is scheduled in the clinical unit, the treatment periods will be split into two parts (treatment periods 1-3 and treatment periods 4-6). This means that you will be required to stay at the clinical unit for the following overnight stays:

  • Treatment Periods 1-3 – total of 4 days with 3 overnight stays
  • Treatment Periods 4-6 – total of 4 days with 3 overnight stays (to be completed approximately 3 days after discharge from the clinical unit in treatment period 3)

In addition, as the treatment periods are split and will run on consecutive days within each split, the procedures to be performed on Day -1 of each treatment period will only be performed on Day -1 of treatment period 1 and 4 respectively i.e., the days on which you will be admitted/re-admitted to the clinical unit. You should therefore ensure that you are available to complete all visits before agreeing to participate in the study.

1 Follow up visit will be required 2-5 days after receiving your last dose

If you complete this part of the study, you will receive a maximum inconvenience payment of £3050.

Study Payment: £1475 to £3050 Apply. Be amazing

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