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Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults

ClinicalTrials.gov ID: NCT05377255

Public ClinicalTrials.gov record NCT05377255. 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.

ClinicalTrials.gov public records Last synced Jul 24, 2026, 4:10 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Open Label, Randomized Study to Investigate the Pharmacokinetics and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adult Participants

Study identification

NCT ID
NCT05377255
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Emergent BioSolutions
Industry
Enrollment
24 participants

Conditions and interventions

Interventions

  • 16 mg naloxone AP003 Combination Product
  • 8 mg naloxone NARCAN Nasal Spray Combination Product

Combination Product

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 27, 2022
Primary completion
May 9, 2022
Completion
May 9, 2022
Last update posted
Apr 14, 2026

2022

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Syneos Health Clinical Research Services Miami Florida 33136

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 NCT05377255, 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 Apr 14, 2026 · Synced Jul 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05377255 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →