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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer - Complete
• Intervention / Treatment: Drug: naloxone IM

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • JCCT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 to 55 years of age
• Body mass index (BMI) 18 to 30 kg/m2
• Subjects who do not take prescribed or OTC medications on a regular basis. In the case of recent sporadic use for minor illness, the subject may be enrolled if the investigator deems the use insignificant to study.
• Nonsmokers and subjects who smoked 10 or fewer cigarettes per day.
• Be willing to spend at least 12 hours in the study facility.

Exclusion Criteria:

• Subjects who do not fulfill criteria as described in Inclusion Criteria above
• Abnormal wrist or forearm anatomy (or history of prior wrist/forearm surgery).
• Difficult venous access for blood draws
• Active infection in including respiratory tract infection
• Used opioid analgesics for pain relief within the previous 14 days, or, in the judgment of the investigator, had significant acute or chronic medical conditions.
• Known previous or concomitant serious illness or medical condition such as malignancy, HIV, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis that in the opinion of the investigator may interfere with participation in the study
• Previous Substance Use Disorder (SUD) with injectable drugs.
• Compromised cardiovascular system (history of myocardial infarction- MI, angina, etc., at discretion of principal investigator- PI).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naloxone intramuscular (IM); intramuscular (IM) to extensor digitorum communis (EDC)/forearm muscle	Drug: naloxone IM; naloxone IM to the EDC/forearm muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Profile (area under the curve AUC)	Area under the Curve (AUC)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Profile (Cmax, Tmax, T/2- half-life)	Pharmacokinetic (PK) profile to include (area under the curve (AUC), maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax) and half life (T/2))	1 day

Collaborators and Investigators

• Sponsor: STAT Therapeutics Inc
• Collaborators: Johnson County ClinTrials
• Investigators: Study Chair: Thomas Krol, PharmD, STAT Therapeutics Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2024
• Primary Completion (Actual): April 8, 2024
• Study Completion (Actual): April 8, 2024

Study Registration Dates

• First Submitted: September 5, 2025
• First Submitted That Met QC Criteria: September 11, 2025
• First Posted (Estimated): September 18, 2025

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: naloxone intramuscular forearm
• Other Study ID Numbers: STAT501-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Healthy volunteers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No