Trial · NCT05377255
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
NCT05377255, Phase 1, Completed, Emergent BioSolutions
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults. Trials, record NCT05377255. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05377255
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
- NCT number
- NCT05377255
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Emergent BioSolutions
- Conditions
- Opioid Overdose
- Interventions
- 16 mg naloxone AP003, 8 mg naloxone NARCAN Nasal Spray
- First posted
- 2022-05-17
- Last updated
- 2026-08-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean naloxone plasma concentration AP003 dosing periods. | PK samples taken at various timepoints over the course of Pre-dose and post-dose for 12 hours. | The mean naloxone plasma concentration during the two AP003 dosing periods. |
| Primary | Mean naloxone plasma concentration Narcan dosing periods | PK samples taken at various timepoints over the course of Pre-dose and post-dose for 12 hours. | The mean naloxone plasma concentration during the two Narcan dosing periods. |
| Primary | Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAE) | Through end of study visit (within 7 days after second dose) | Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAE) by treatment thru End of Study Visit (within 7 days after 2nd dose). |
| Primary | Incidence of abnormal vital signs | Through end of study visit (within 7 days after second dose) | Incidence of abnormal vital signs (heart rate, blood pressure, and respiration rate) by treatment thru End of Study Visit (within 7 days after 2nd dose). |
| Primary | Incidence of clinically significant ECG | Through end of study visit (within 7 days after second dose) | Incidence of clinically significant ECG by treatment thru End of Study Visit (within 7 days after 2nd dose). |
| Primary | Incidence of clinical laboratory changes | Through end of study visit (within 7 days after second dose) | Incidence of clinical laboratory changes by treatment thru End of Study Visit (within 7 days after 2nd dose). |
| Primary | Incidence of adverse events of special interest (AESI) indicating of nasal irritation | Through end of study visit (within 7 days after second dose) | Incidence of adverse events of special interest (AESI) indicating of nasal irritation (erythema, edema, and erosion) by treatment thru End of Study Visit (within 7 days after 2nd dose). |
| Primary | Incidence of changes in B-SIT assessment | Through end of study visit (within 7 days after second dose) | Incidence of changes in B-SIT assessment within an AP003 period thru End of Study Visit (within 7 days after 2nd dose). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42332351 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05377255
GET https://conductscience.org/api/trials/v1/NCT05377255/registered