drugset / Trial / NCT07228325
Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis
RandomizedSequentialOpen-labelTreatment
Summary
The study will evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) responses of FMXIN002, an intranasal epinephrine powder, compared with the EpiPen® intramuscular autoinjector, after single and double doses, in healthy adults with a history of allergic rhinitis.
Timeline
- Start
- 2025-11-03
- Primary completion
- 2026-03
- Completion
- 2026-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epinephrine | Other / unclassified | 0.3 mg | Intramuscular |
| Subject | FMXIN002 | Unknown | 4 mg | Intranasal |