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

NCT05377255 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-15

No results posted yet for this 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.

Conditions

Interventions

COMBINATION_PRODUCT

16 mg naloxone AP003

4 doses of 4 mg each (total: 16 mg) of naloxone through the AP003 device

COMBINATION_PRODUCT

8 mg naloxone NARCAN Nasal Spray

2 doses of 4 mg each (total: 8 mg) of the naloxone through the NARCAN Nasal Spray device

Sponsors & Collaborators

  • Emergent BioSolutions

    lead INDUSTRY

Principal Investigators

  • Nino Joy, MD · Emergent BioSolutions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2022-05-10
Completion
2022-05-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05377255 on ClinicalTrials.gov