Clinical Study of Allergic Reactions

Back to Trials

If you are a healthy male or female aged between 18 and 55 with a known peanut allergy, you may be eligible to participate in a study investigating a new drug being developed for the potential treatment of severe allergic reactions.

Study Payment* £2,050.

Apply for this study

*Terms & Conditions apply.

Study Payment: £2050

"*" indicates required fields

Step 1 of 3

This field is hidden when viewing the form

Advertising Source

* indicates a required field

By agreeing to this form and selecting the box as outlined below, 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 in our policy linked 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.

Agreement*

I understand and wish to proceed

* indicates a required field

Your details

First Name*

Last Name*

Gender at Birth

Date of Birth*

This field is hidden when viewing the form

Age

Height*

Weight*

Your BMI

This field is hidden when viewing the form

BMI Calc

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.

Race*

Your Race*

Street Address*

City*

Postcode*

Phone Number*

Email*

Can we contact you by email?

Yes

Can we contact you by SMS?

Yes

Can we contact you by phone?

Yes

Please select at least one contact mechanism to facilitate your participation in future clinical studies.

Study Information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate the study drug, P2-101 (active ingredient adrenaline in the form of tablet which dissolves under the tongue) in comparison with the very common injectable form of adrenaline (administered as an injection directly into the muscle) used in the treatment of severe allergic reactions and a placebo treatment (containing no active study drug).

The main objectives of the study are as follows:

To evaluate the effectiveness of P2-101 when it is administered as a single dose on one occasion, in comparison with an adrenaline injection and a placebo treatment.

To investigate the effect of P2-101 on the body through the measurement of specific safety parameters e.g., vital signs, heart activity monitoring and blood sugars.

To evaluate the general safety, tolerability of P2-101 when it is administered as a single dose on one occasion, in comparison with an adrenaline injection and a placebo treatment.

To investigate the concentration of P2-101 in the blood, how this changes over time and to evaluate whether the concentration of P2-101 is similar to the concentration observed in the blood for injectable adrenaline following administration of single doses

Blood samples and other measures as described will be taken at set time points throughout the study to measure the effectiveness of P2-101 in comparison with the adrenaline injection. In the context of the whole study, we will analyse the results from each of the treatment periods and combine this information in order to better understand how P2-101 works in the body and to determine how comparably effective P2-101 is when used in the treatment of allergic reaction. The purpose of the data generated in this study is to provide further information and guidance to support the study Sponsor in the development of the study drug, P2-101

P2-101 is being developed for the treatment of severe allergic reactions. Currently, there are multiple injectable forms of adrenaline 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 adrenaline which could be more effective and reduce these challenges.

If you require any further information or would like to speak with a member of the team before applying please see contact details at the bottom of this page. On successful application you will receive the full clinical study information sheet and consent form, to aid any questions and queries you may have about participating in this trial.

Ready? Let’s get started

Purpose and Timeline

The purpose of the study is to evaluate the study objectives when P2-101, an adrenaline injection and a placebo treatment are administered as single doses across two treatment periods. The study will consist of up to 12 participants who have a known peanut allergy (documented within the last 12 months and confirmed via allergy testing at screening) with a minimum of 10 participants required to complete both treatment periods

Across the two treatment periods, each participant will receive:

A single dose of P2-101 (15 milligrams (mg)) in the form of a sublingual tablet (tablet which is placed under the tongue and dissolves naturally) with a placebo injection (containing no study drug).

A single dose of injectable adrenaline (0.3 mg) with a placebo sublingual tablet.

Prior to dose administration in each treatment period, participants will be required to undertake a food challenge whereby they will be asked to eat a food product containing peanuts (e.g., peanut cookies or peanut powder as a paste in natural yoghurt) to trigger an allergic reaction.

If you participate in this study, you will be required to stay at the Simbec-Orion clinical unit
for a maximum period of 2 days (1 overnight stay) per treatment period for a maximum of two treatment periods.

If you participate in this study, you will be required complete the study visits at the clinical unit as follows:

One Screening Visit – Within 35 days of treatment period one.

Two Treatment Periods – Day -1 to Day 1 (one overnight stay, two days overall duration). Each dose in each treatment period will be separated by a period of
at least 7 days

You should ensure that you are able to commit to completing all visits before agreeing to participate in this study.

If you participate in this part of the study, you will receive an inconvenience payment for the inconvenience of participating in and satisfactorily completing the study including all procedures and the post-study follow up visit, along with the highest level of compliance.

Screening Visit: £100
Total Inconvenience Payment: £2050
Travel Expenses: £75 (per visit)

Screening Visit
Day -35 to Day -2

Treatment Period One

Day -1 (admission) to Day 1 (discharge).

Treatment Period Two

Day -1 (admission) to Day 1 (discharge)

Post Study Follow-up Telephone Call

5 to 7 days following you last dose.

Apply Now. Be Amazing

Clinical Study 36676

If you are a healthy male or female aged between 18 and 55 with a known peanut allergy, you may be eligible to participate in a study investigating a new drug being developed for the potential treatment of severe allergic reactions.

Study Payment* £2,050.

Your details

Study Information

Let's get started