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Proof of Concept (PoC) Evaluation of Naloxone Unique Intramuscular (IM) Injection

NCT07180420 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-18

No results posted yet for this study

Summary

WHAT IS THE PURPOSE OF THIS RESEARCH STUDY

This research study is designed to demonstrate that intramuscular (IM) Injection of FDA Approved Naloxone Hydrochloride (HCI) given in the forearm muscle is approximately the same as given the injection in the buttocks muscle. STAT Therapeutics Inc. is sponsoring this research study.

BACKGOUND AND PURPOSE FOR THIS STUDY

You are being asked to participate in this research study because you are between the ages of 18 and 55 and appear to be in stable health. Naloxone HCI is FDA approved and has been used to treat symptoms of opioid overdose for over 40 years. This research study is designed to demonstrate that intramuscular (IM) Injection of FDA Approved Naloxone Hydrochloride (HCI) given in the forearm is approximately the same as given the injection in the buttocks.

This is the first time Naloxone Hydrochloride (HCI) is given in the forearm muscle.

This is an open-label study. This means that you, the Doctor, study staff, and the Sponsor will know the study drug and the dose that you are given.

Conditions

  • Healthy Volunteer - Complete

Interventions

DRUG

naloxone IM

naloxone IM to the EDC/forearm muscle

Sponsors & Collaborators

  • Johnson County ClinTrials

    collaborator UNKNOWN

  • STAT Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Thomas Krol, PharmD · STAT Therapeutics Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-03-24
Primary Completion
2024-04-08
Completion
2024-04-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07180420 on ClinicalTrials.gov