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Corticosteroid

DESF for Allergy

Phase 2

Recruiting

Led By Frank Lee, MD

Research Sponsored by Aquestive Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to tolerate venipuncture

BMI ≥18 kg/m2 to ≤32 kg/m2

Must not have

Known history or presence of hypersensitivity or idiosyncratic reaction to DESF, epinephrine, or other drug substances with similar activity including intolerance or hypersensitivity to any component of DESF

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 20 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how epinephrine is processed in the body when given as a single dose and multiple doses to healthy adults with oral allergy syndrome. Participants will first undergo an allergen challenge before

Who is the study for?

This trial is for healthy adults with Oral Allergy Syndrome (OAS), which causes mouth and throat reactions after eating certain raw fruits or vegetables. Participants must be able to undergo an allergen challenge and receive DESF, a form of epinephrine.

What is being tested?

The study tests how the body processes DESF, a drug used for allergic reactions, in people with OAS. It compares the effects of single and repeated doses after an allergen challenge versus doses without it, including one period comparing to standard intramuscular epinephrine.

What are the potential side effects?

Possible side effects include those typical of epinephrine: rapid heartbeat, anxiety, headache, shakiness, dizziness, sweating. Reactions at the site where DESF is administered may also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can undergo blood draws without any issues.

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My BMI is between 18 and 32.

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I am between 18 and 55 years old and healthy.

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I weigh at least 50 kg if male, or 45 kg if female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to DESF, epinephrine, or similar drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 240 minutes post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 240 minutes post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 240 minutes post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC0-10

AUC0-20

AUC0-30

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Single Doses of DESF and Intramuscular Manual InjectionExperimental Treatment2 Interventions

Single dose of DESF (12 mg) administered after allergen challenge (Treatment Period 1), followed by a single dose of intramuscular (IM) manual injection (0.3 mg) without allergen challenge after a 24-hour washout period (Treatment Period 2), followed by a single dose of DESF (12 mg) without allergen challenge after a 14-day washout period from Treatment Period 1.

Group II: Repeat Doses of DESF and Intramuscular Manual InjectionExperimental Treatment2 Interventions

Repeat dose of DESF (24 mg \[12 mg x 2\]) administered after allergen challenge (Treatment Period 1), followed by a repeat dose of IM manual injection (0.6 mg \[0.3 mg x 2\]) without allergen challenge after a 24-hour washout period (Treatment Period 2), followed by a repeat dose of DESF (24 mg \[12 mg x 2\]) without allergen challenge after a 14-day washout period from Treatment Period 1.

0 / 5Eligibility criteria met