Allergic ReactionPhase 1PARKSNCT07703982
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of DESF in Pediatric Subjects
A Phase 1 study testing DESF in people with Allergic Reaction, run by Aquestive Therapeutics at 8 sites in 2 countries.
Trial summary
An open-label study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of epinephrine administered as a single dose of DESF in pediatric subjects weighing ≥30 kg with a personal history of allergic reactions and are at high risk for serious allergic reactions. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Allergic Reaction
- What is being tested?
- DESF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 26 Dec 2024to 21 May 2025
- Phase
- Phase 1
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children ages 7 through 17 years of age at the start of the Screening Period.
- Participants with a known history of allergic reactions with an active prescription for epinephrine, and who (in the judgement of the investigator) are at high risk for serious allergic reactions (e.g., anaphylaxis).
- Participant has a body weight ≥30 kg (66 lbs).
- Participant is within the 5th and 95th percentiles, inclusive, for weight by age (according to CDC growth charts).
Who cannot join
- Any current or past medical conditions such as significant systemic diseases that, in the investigator's opinion, might significantly affect pharmacodynamic responses to DESF.
- Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases.
- Known intolerance or hypersensitivity to any component of DESF.
- Participant has a disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of DESF.
- Positive urine drug screen, saliva alcohol test, or urine cotinine test at Screening or prior to administration of DESF on Study Day 1.
- Participant has participated in any clinical investigation within the 30 days prior to the planned administration of DESF on Study Day 1.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
AllerVie Clinical Research
Birmingham, Alabama, 35209
Texas Children's Hospital - Feigin Center
Houston, Texas, 77030
UCLA Pediatric Allergy & Immunology
Los Angeles, California, 90095
Rochester Regional Health AIR
Rochester, New York, 14607
J. Lewis Research Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
IAA Clinical Research
Wheaton, Maryland, 20902
About this study
Official title: A Phase 1, Multi-Site, Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of DESF in Pediatric Subjects ≥30 kg With a Personal History of Allergic Reactions at High Risk for Serious Reactions (PARKS: Pediatric Anaphylm Response, Kinetics, and Safety)
An open-label study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of epinephrine administered as a single dose of DESF in pediatric subjects weighing ≥30 kg with a personal history of allergic reactions and are at high risk for serious allergic reactions. All treated participants will receive a single dose of DESF on Study Day 1. On Study Day 2, participants will return to the study site for an Oral Mucositis Assessment Scale (OMAS) assessment.
Read the detailed description
This is a Phase 1, multi-site, open-label, single treatment study conducted in male and female pediatric subjects (age 7-17 years) who have a have a personal history of allergic reactions and are at high risk for serious allergic reactions. This study is designed to evaluate the pharmacokinetics (PK) of epinephrine administered as a single dose of DESF.
Up to 24 DESF treated pediatric participants are expected to be enrolled. The study population will consist of healthy, non-smoking, pediatric male and female participants aged 7 through 17 with a known history of allergic reactions that the investigators believe continue to remain at high risk of serious allergic reactions (e.g., anaphylaxis).
All treated participants will be administered a single, 12 mg, dose of DESF on Study Day 1. No other investigational product will be administered.
The expected maximum duration of an individual's participation in this study will be, approximately, 32 days including a 30-day Screening Period, a 1-day Treatment Period (Study Day 1) and a 1-day (±1 day) Post-treatment Follow-up (Study Day 2).
- Conditions
- Allergic Reaction
- Being tested
- DESF
- 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
| Study group | Role | What they receive |
|---|---|---|
| Single Dose of DESF | Experimental | A single dose (12 mg) of DESF administered. Receives: Drug: DESF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Baseline Corrected Maximum Epinephrine Plasma 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 posted15 Jul 2026
- Study start26 Dec 2024
- Primary completion14 Mar 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquestive Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703982
- Sponsor's protocol ID
- AQ109302
- Acronym
- PARKS
- Status last verified
- Jul 2026
- First submitted
- 17 Dec 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-Site, Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of DESF in Pediatric Subjects ≥30 kg With a Personal History of Allergic Reactions at High Risk for Serious Reactions (PARKS: Pediatric Anaphylm Response, Kinetics, and Safety)
- ClinicalTrials.gov ID
- NCT07703982
- Acronym / sponsor ID
- PARKS / AQ109302
- Conditions
- Allergic Reaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aquestive TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 15 Jul 2026 (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.
An open-label study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of epinephrine administered as a single dose of DESF in pediatric subjects weighing ≥30 kg with a personal history of allergic reactions and are at high risk for serious allergic reactions. All treated participants will receive a single dose of DESF on Study Day 1. On Study Day 2, participants will return to the study site for an Oral Mucositis Assessment Scale (OMAS) assessment.
Detailed description
This is a Phase 1, multi-site, open-label, single treatment study conducted in male and female pediatric subjects (age 7-17 years) who have a have a personal history of allergic reactions and are at high risk for serious allergic reactions. This study is designed to evaluate the pharmacokinetics (PK) of epinephrine administered as a single dose of DESF.
Up to 24 DESF treated pediatric participants are expected to be enrolled. The study population will consist of healthy, non-smoking, pediatric male and female participants aged 7 through 17 with a known history of allergic reactions that the investigators believe continue to remain at high risk of serious allergic reactions (e.g., anaphylaxis).
All treated participants will be administered a single, 12 mg, dose of DESF on Study Day 1. No other investigational product will be administered.
The expected maximum duration of an individual's participation in this study will be, approximately, 32 days including a 30-day Screening Period, a 1-day Treatment Period (Study Day 1) and a 1-day (±1 day) Post-treatment Follow-up (Study Day 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Dose of DESF | Experimental | Drug: DESFA single dose (12 mg) of DESF administered. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male and female children ages 7 through 17 years of age at the start of the Screening Period.
- Participants with a known history of allergic reactions with an active prescription for epinephrine, and who (in the judgement of the investigator) are at high risk for serious allergic reactions (e.g., anaphylaxis).
- Participant has a body weight ≥30 kg (66 lbs).
- Participant is within the 5th and 95th percentiles, inclusive, for weight by age (according to CDC growth charts).
Key exclusion criteria (6 listed)
- Any current or past medical conditions such as significant systemic diseases that, in the investigator's opinion, might significantly affect pharmacodynamic responses to DESF.
- Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases.
- Known intolerance or hypersensitivity to any component of DESF.
- Participant has a disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of DESF.
- Positive urine drug screen, saliva alcohol test, or urine cotinine test at Screening or prior to administration of DESF on Study Day 1.
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 | Single Dose of DESF |
Primary outcome
Cmax
Time frame: 0 to 240 minutes post-dose
Baseline Corrected Maximum Epinephrine Plasma 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 15 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DESF in people with Allergic Reaction, run by Aquestive Therapeutics at 8 sites in 2 countries.
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 4 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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 15 Jul 2026.