A Phase 2 interventional study of DESF and Epinephrine Injection in Allergic Reaction, sponsored by Aquestive Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Aquestive Therapeutics · Phase 2, Interventional, and Treatment
Among 300 studies in Hypersensitivity with a site in United States — 32 open to participants now, 40 under way, 1 of them phase 3. Hypersensitivity · United States.
Among the 300 studies in Hypersensitivity with a site in United States, this one is the 143rd largest by enrollment of the 220 interventional ones that give a count, is one of 4 that started in 2024, is one of 49 in phase 2, and was the 279th registered.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
Browse Hypersensitivity studies →32 of the 300 studies in Hypersensitivity with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 12+
Lumicell, Inc. · Sites in United States
Ages 18+
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 12–50
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 12 mo–17 yrs
Qifeng Zhang · Sites in United States, China
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 100 Hypersensitivity studies recruiting now, 37 (37%) set no upper age limit and 51 (51%) stop at 75 or younger; 55 take children under 18; 36 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
300 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 63 · Phase 3 41 · Phase 4 18
First in 1996; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Median enrollment 60 across the 220 interventional studies, 200 across the 76 observational. Of the 243 that completed or were terminated, 104 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
117 of 300 have an industry lead sponsor. The 10 most frequent:
Aquestive Therapeutics is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Aquestive Therapeutics has 2 studies filed under Hypersensitivity — fewer than ten, so there is no comparison to draw.
11 of the studies in Hypersensitivity with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07003919Phase 3DBV TechnologiesSafety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers) | 2026-11 |
| NCT05584488Columbia UniversityAllergy and Immunology Natural History Study | 2027-01 |
| NCT07447869National Institute of Allergy and Infectious Diseases (NIAID)LYmph Node eXamination in Cat Allergen Immunotherapy | 2027-01-27 |
| NCT03914664Vanderbilt University Medical CenterNeural Correlates of Sensory Phenomena in Tourette Syndrome | 2027-02-28 |
| NCT06834165ARS Pharmaceuticals, Inc.Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy | 2027-04 |
Add all 11 to your calendar (.ics) → With an account.
Among the 300 studies in Hypersensitivity with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A 2-part open-label study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as single and repeat doses of DESF in healthy adults with oral allergy syndrome (OAS). In both parts, subjects undergo an oromucosal allergen challenge prior to administration of DESF according to randomization into two cohorts. In Part 1, 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). In Part 2, there are two treatment periods evaluating single and repeat doses of study drug, DESF after an allergen challenge (Treatment Period 1) and intramuscular (IM) injection without allergen challenge (Treatment Period 2).
This is a 2-Part, 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. In both Part 1 and Part 2, 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.
Part 1:
Up to 36 subjects will be enrolled in Part 1.
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.
Part 2:
Up to 12 subjects who have completed Part 1 (6 from each cohort) may continue to Part 2.
Treatment Period 1: Following the allergen challenge, subjects receive a single or repeat dose of DESF based on randomization in Part 1.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: DESF · Drug: Epinephrine Injection
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.
Drug: DESF · Drug: Epinephrine Injection
DESF administered in the sublingual space.
Epinephrine manual injection administered intramuscularly according to the approved prescribing information.
Cmax
Baseline Corrected Maximum Epinephrine Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
Time frame: 0 to 240 minutes post-dose
AUC0-10
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 10 minutes
Time frame: 0 to 10 minutes
AUC0-20
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 20 minutes
Time frame: 0 to 20 minutes
AUC0-30
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 30 minutes
Time frame: 0 to 30 minutes
AUC0-45
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 45 minutes
Time frame: 0 to 45 minutes
Ran from Jul 2024 to primary completion in Oct 2024, 2 months.
Of 30 phase 2 interventional studies under Hypersensitivity, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 51. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Epinephrine
Aquestive Therapeutics