A 2-part BA study to compare PK in 3 formulations of adrenaline
Research type
Research Study
Full title
A single-centre, open-label, randomised, 2-part, crossover, comparative bioavailability study to assess adrenaline plasma concentrations in healthy volunteers following administrations of KL-01401 (test product) and an adrenaline injection (reference product)
IRAS ID
305647
Contact name
Helen Philpott
Contact email
Sponsor organisation
Klaria AB
Eudract number
2021-003701-21
Duration of Study in the UK
0 years, 4 months, 25 days
Research summary
The purpose of this study is to investigate the study drug adrenaline.\n\nThe objectives are:\n- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of adrenaline when it is administered as single doses in 3 different formulations i.e., as an oral mucosal film (a film which sticks to the inside of the cheek – KL-01401), an EpiPen® Auto Injector (administering the drug directly into a muscle) and as a subcutaneous injection (injection into the tissue layer between the skin and muscle).\n\n- To investigate the concentration of adrenaline in the blood, determining whether there are differences in the concentration between different forms of adrenaline.\n \n- To evaluate and compare how the position of KL-01401 in the mouth affects the concentration of adrenaline in the blood.\n\n- To assess different factors for the KL-01401 film including the irritation in the mouth and how the film ‘sticks’ to the inside of the mouth based on where the film is placed.\n\n- To evaluate the bioavailability (the degree and rate at which a substance (such as a drug) is absorbed into the body or is made available at the site of its’ desired effect) of adrenaline as an oral mucosal film in comparison with a marketed product (EpiPen®).\n\nThis study will be split into 2 parts: Parts A & B.\nPart A will investigate adrenaline when it is given as single doses in 3 different forms and Part B will investigate adrenaline when it is given as single doses in 2 different forms. Part A will enrol 12 participants and Part B will enrol a minimum of 12 participants.\n\nBlood samples will be taken in order to measure the concentration of adrenaline in the blood and this will be compared between the different forms of adrenaline. \n
REC name
Wales REC 2
REC reference
21/WA/0348
Date of REC Opinion
16 Nov 2021
REC opinion
Favourable Opinion