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NCT06527937 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome
A Phase 2 study, sponsored by Aquestive Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT06527937 is a Phase 2 study that has completed, run by Aquestive Therapeutics. The registered enrollment target is 36 participants.
The verdict
NCT06527937, a Phase 2 study, has completed, sponsored by Aquestive Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study 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). 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).
Interventions
- DRUG DESF
- DRUG Epinephrine Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-07-17 |
| Est. Completion | 2024-10-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06527937
The ClinicalTrials.gov registry entry for NCT06527937 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aquestive Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which DESF is the first listed.
NCT06527937 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06527937 about?
NCT06527937 is a clinical study titled "Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome". 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 ...
What is the current status of trial NCT06527937?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2024-07-17. Estimated completion is 2024-10-13.
What interventions are being tested in trial NCT06527937?
The interventions under investigation include: DESF (DRUG), Epinephrine Injection (DRUG).
Who is sponsoring clinical trial NCT06527937?
This trial is sponsored by Aquestive Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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