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NCT05377255 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
A Phase 1 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT05377255 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 24 participants.
The verdict
NCT05377255, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
Interventions
- COMBINATION_PRODUCT 16 mg naloxone AP003
- COMBINATION_PRODUCT 8 mg naloxone NARCAN Nasal Spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2022-05-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05377255
The ClinicalTrials.gov registry entry for NCT05377255 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emergent BioSolutions, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 16 mg naloxone AP003 is the first listed.
NCT05377255 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05377255 about?
NCT05377255 is a clinical study titled "Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults". This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
What is the current status of trial NCT05377255?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-03-28. Estimated completion is 2022-05-10.
What interventions are being tested in trial NCT05377255?
The interventions under investigation include: 16 mg naloxone AP003 (COMBINATION_PRODUCT), 8 mg naloxone NARCAN Nasal Spray (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05377255?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
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