Allergic ReactionPhase 2OASISNCT06527937
Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome
A Phase 2 study testing DESF and Epinephrine Injection in people with Allergic Reaction, run by Aquestive Therapeutics at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Reaction
- What is being tested?
- DESF and Epinephrine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to 13 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing and able to provide written informed consent and capable of following the protocol-required guidelines.
- Healthy males and females 18 through 55 years of age.
- Body weight ≥50 kg for males and ≥45 kg for females.
- BMI ≥18 kg/m2 to ≤32 kg/m2.
- Known history of oral allergy syndrome in response to exposure to any of the allergens (e.g., apple, cherry, mango, melon, kiwi, celery, banana and/or carrot).
- Able to tolerate venipuncture.
- Subject has not had exposure to antihistamines within 3 days prior to the Screening visit.
Who cannot join
- Any current 'clinically significant' medical condition(s) that, in the opinion of the investigator, could confound the assessment of safety or impact assessments of PK and/or PD parameters or the safety of the subjects in the trial such as significant systemic neurological, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, oncologic and/or metabolic disease.
- Clinically significant laboratory results at Screening, including, but not limited to hemoglobin <11.5 g/dL for males or <10.5 g/dL for females.
- Clinically significant 12-lead ECG findings (at any time).
- 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.
- Known history or presence of any disorder of the sublingual mucosa or any disease or condition which affects the normal production of saliva (e.g., xerostomia, Ehlers-Danlos syndrome, or Sjögren's syndrome) which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Subject has a disorder of the sublingual mucosa that, in the opinion of the investigator, would impact or interfere with administration, retention or absorption of DESF.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services, Inc.
Secaucus, New Jersey, 07094
About this study
Official title: A 2-Part, Phase 2, Open-Label, Randomized, Fixed Sequence Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Epinephrine After Single and Repeat Doses of DESF in Healthy Adults With Oral Allergy Syndrome (OASIS: Oral Anaphylm Symptom Intervention Study)
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).
Read the detailed description
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.
- Conditions
- Allergic Reaction
- Being tested
- DESF, Epinephrine Injection
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESFDrug
DESF administered in the sublingual space.
Epinephrine InjectionDrug
Epinephrine manual injection administered intramuscularly according to the approved prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Single Doses of DESF and Intramuscular Manual Injection | Experimental | 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. Receives: Drug: DESF; Drug: Epinephrine Injection |
| Repeat Doses of DESF and Intramuscular Manual Injection | Experimental | 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. Receives: Drug: DESF; Drug: Epinephrine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Baseline Corrected Maximum Epinephrine Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
Measured: 0 to 240 minutes post-dose
AUC0-10
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 10 minutes
Measured: 0 to 10 minutes
AUC0-20
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 20 minutes
Measured: 0 to 20 minutes
AUC0-30
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 30 minutes
Measured: 0 to 30 minutes
AUC0-45
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 45 minutes
Measured: 0 to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start17 Jul 2024
- Primary completion10 Oct 2024
- Study completion13 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquestive Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Lee, MD, Principal investigator, Frontage Clinical Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527937
- Sponsor's protocol ID
- AQ109206
- Acronym
- OASIS
- Status last verified
- Nov 2024
- First submitted
- 26 Jul 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nowak-Wegrzyn A, Fleischer DM, Lieberman JA, Golden DBK, Kilroy E, Slatko G, Rance K, Greenhawt M. Pharmacokinetics and pharmacodynamics of AQST-109 sublingual film in oral allergy syndrome: A phase 2 study. Ann Allergy Asthma Immunol. 2026 Jun 28:S1081-1206(26)00273-5. doi: 10.1016/j.anai.2026.06.012. Online ahead of print.
PubMed 42365874
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part, Phase 2, Open-Label, Randomized, Fixed Sequence Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Epinephrine After Single and Repeat Doses of DESF in Healthy Adults With Oral Allergy Syndrome (OASIS: Oral Anaphylm Symptom Intervention Study)
- ClinicalTrials.gov ID
- NCT06527937
- Acronym / sponsor ID
- OASIS / AQ109206
- Conditions
- Allergic Reaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Aquestive TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 13 Oct 2024 (actual)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Doses of DESF and Intramuscular Manual Injection | Experimental | Drug: DESF, Drug: Epinephrine InjectionSingle 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. |
| Repeat Doses of DESF and Intramuscular Manual Injection | Experimental | Drug: DESF, Drug: Epinephrine InjectionRepeat 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Willing and able to provide written informed consent and capable of following the protocol-required guidelines.
- Healthy males and females 18 through 55 years of age.
- Body weight ≥50 kg for males and ≥45 kg for females.
- BMI ≥18 kg/m2 to ≤32 kg/m2.
- Known history of oral allergy syndrome in response to exposure to any of the allergens (e.g., apple, cherry, mango, melon, kiwi, celery, banana and/or carrot).
Key exclusion criteria (6 listed)
- Any current 'clinically significant' medical condition(s) that, in the opinion of the investigator, could confound the assessment of safety or impact assessments of PK and/or PD parameters or the safety of the subjects in the trial such as significant systemic neurological, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, oncologic and/or metabolic disease.
- Clinically significant laboratory results at Screening, including, but not limited to hemoglobin <11.5 g/dL for males or <10.5 g/dL for females.
- Clinically significant 12-lead ECG findings (at any time).
- 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.
- Known history or presence of any disorder of the sublingual mucosa or any disease or condition which affects the normal production of saliva (e.g., xerostomia, Ehlers-Danlos syndrome, or Sjögren's syndrome) which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DESFDESF administered in the sublingual space. | Drug | Repeat Doses of DESF and Intramuscular Manual Injection, Single Doses of DESF and Intramuscular Manual Injection |
| Epinephrine InjectionEpinephrine manual injection administered intramuscularly according to the approved prescribing information. | Drug | Repeat Doses of DESF and Intramuscular Manual Injection, Single Doses of DESF and Intramuscular Manual Injection |
Primary outcome
Cmax
Time frame: 0 to 240 minutes post-dose
Baseline Corrected Maximum Epinephrine Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
AUC0-10
Time frame: 0 to 10 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 10 minutes
AUC0-20
Time frame: 0 to 20 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 20 minutes
AUC0-30
Time frame: 0 to 30 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 30 minutes
AUC0-45
Time frame: 0 to 45 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 45 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Derived from this study: PubMed 42365874Nowak-Wegrzyn A, Fleischer DM, Lieberman JA, Golden DBK, Kilroy E, Slatko G, Rance K, Greenhawt M. Pharmacokinetics and pharmacodynamics of AQST-109 sublingual film in oral allergy syndrome: A phase 2 study. Ann Allergy Asthma Immunol. 2026 Jun 28:S1081-1206(26)00273-5. doi: 10.1016/j.anai.2026.06.012. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Lee, MD principal investigator
Frontage Clinical Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DESF and Epinephrine Injection in people with Allergic Reaction, run by Aquestive Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 0 to 240 minutes post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06527937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.