Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527937
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome OAS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Open-Label Randomized Fixed Sequence Study to Evaluate the Pharmacokinetics of Epinephrine After Single and Repeat Doses of DESF in Healthy Adults With Oral Allergy Syndrome OAS
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An open-label study to assess the pharmacokinetics PK of epinephrine administered as single and repeat doses of DESF in healthy adults with oral allergy syndrome OAS Subjects undergo an oromucosal allergen challenge prior to administration of DESF according to randomization into two cohorts There are three treatment periods evaluating single and repeat doses of study drug DESF after an allergen challenge Treatment Period 1 intramuscular IM injection without allergen challenge Treatment Period 2 and DESF without allergen challenge Treatment Period 3
Detailed Description:
This is a Phase 2 open-label three-period six-treatment fixed sequence stratified study conducted in healthy male and female adult subjects age 18-55 years who have oral allergy syndrome OAS designed to evaluate the pharmacokinetics PK of epinephrine administered as single and repeat doses of DESF with allergen-challenge induced oral physiological changes compared to the PK of epinephrine administered as single and repeat doses of intramuscular IM injection and single and repeat doses of DESF without allergen challenge All subjects undergo an allergen challenge prior to Treatment Period 1 Provided the allergen challenge elicits at least mild symptoms of oral physiological changes subjects are randomized into one of two cohorts to receive either single or repeat doses of study drug throughout the study
Allergen Challenge The oromucosal allergen challenge begins approximately 20 minutes before the expected administration of DESF Subjects have a single food allergen known to trigger an allergic reaction in the subject placed on their tongue for up to 15 minutes after initial exposure to upper and lower lips and gums Subjects keep the allergen in place for up to 15 minutes until symptoms are reported The subjects are monitored from the start of the allergen challenge to determine severity of symptoms The allergen is then removed from the mouth and within 5 minutes subjects rate their symptoms and DESF is administered
Treatment Period 1 Following the allergen challenge subjects receive a single or repeat dose of DESF based on randomization
Treatment Period 2 Subjects who complete Treatment Period 1 and a minimum 24-hour washout period receive either a single or repeat dose of manual IM epinephrine injection without an allergen challenge based on the randomization
Treatment Period 3 Subjects who complete Treatment Period 1 and Treatment Period 2 undergo a minimum 14-day washout period from Treatment Period 1 Subjects are administered a single or repeat dose of DESF without an allergen challenge based on randomization
Allergen Challenge The oromucosal allergen challenge begins approximately 20 minutes before the expected administration of DESF Subjects have a single food allergen known to trigger an allergic reaction in the subject placed on their tongue for up to 15 minutes after initial exposure to upper and lower lips and gums Subjects keep the allergen in place for up to 15 minutes until symptoms are reported The subjects are monitored from the start of the allergen challenge to determine severity of symptoms The allergen is then removed from the mouth and within 5 minutes subjects rate their symptoms and DESF is administered
Treatment Period 1 Following the allergen challenge subjects receive a single or repeat dose of DESF based on randomization
Treatment Period 2 Subjects who complete Treatment Period 1 and a minimum 24-hour washout period receive either a single or repeat dose of manual IM epinephrine injection without an allergen challenge based on the randomization
Treatment Period 3 Subjects who complete Treatment Period 1 and Treatment Period 2 undergo a minimum 14-day washout period from Treatment Period 1 Subjects are administered a single or repeat dose of DESF without an allergen challenge based on randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None