NCT05099614

Naloxone Auto-injection in Healthy Volunteers

Naloxone Administration Via Auto-injection in Healthy Volunteers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use. This is a single-site feasibility study designed to test the mobile application with a commercially available drug delivery device called the SmartDose by West Pharmaceuticals, Inc. The SmartDose is a wearable self-injection device that can deliver a drug under the skin with a push of a button. Naloxone is a drug used to reverse the effects of opioid drugs in the body. This study will evaluate if the mobile application can wireless trigger the delivery of a small dose of naloxone to a healthy adult volunteer.

Conditions

• Overdose Antidote

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system	1.2 mg of naloxone hydrochloride is administered to healthy adults using the SmartDose wearable auto injector and the mobile respiratory sensing system.

Timeline

• Start date: 2021-03-10
• Primary completion: 2021-04-05
• Completion: 2021-04-05
• First posted: 2021-10-29
• Last updated: 2021-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study