Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
Public ClinicalTrials.gov record NCT07891780. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 2, open-label, single-arm study will evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single dose of epinephrine nasal spray (ENS) in children and adolescents 2 to 17 years of age with a diagnosed Type I allergy. Approximately 44 participants will be enrolled in two body-weight cohorts. * Participants weighing \>30 kg will receive a single 5.25 mg dose of ENS, and * Participants weighing ≥15 kg to ≤30 kg will receive a single 2.5 mg dose of ENS. The study will assess plasma epinephrine concentrations, changes in blood pressure and pulse rate, and safety and tolerability following administration of ENS. Participants will be monitored for 4 hours after dosing and will complete safety follow-up through approximately Day 15.
Study identification
- NCT ID
- NCT07891780
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 44 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 28, 2026 (Estimated)
- Primary completion
- May 8, 2027 (Estimated)
- Completion
- Jun 30, 2027 (Estimated)
- Last update posted
- Oct 23, 2026
2026 – 2027
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CenExel | Marlton | New Jersey | 08053 | — |
| CenExel | Salt Lake City | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07891780, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 23, 2026 · Synced Nov 10, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07891780 live on ClinicalTrials.gov.