Proof of Concept (PoC) Evaluation of Naloxone Unique Intr... | NCT07180420

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

NCT07180420

Sponsor

STAT Therapeutics Inc

Status

Completed

Last Update Posted

Sep 18, 2025Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy Volunteer - Complete

Interventions

naloxone IM

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 24, 2024Actual

Primary Completion Date

Apr 8, 2024Actual

Completion Date

Apr 8, 2024Actual

First Submitted Date

Sep 5, 2025

First Submission Date that Met QC Criteria

Sep 11, 2025

First Posted Date

Sep 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2025

Last Update Posted Date

Sep 18, 2025Actual

Name	Class
Johnson County ClinTrials	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

WHAT IS THE PURPOSE OF THIS RESEARCH STUDY

BACKGOUND AND PURPOSE FOR THIS STUDY

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Naloxone intramuscular (IM)	Experimental	intramuscular (IM) to extensor digitorum communis (EDC)/forearm muscle	Drug: naloxone IM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
naloxone IM	Drug	naloxone IM to the EDC/forearm muscle	Naloxone intramuscular (IM)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Thomas Krol, PharmD	STAT Therapeutics Inc	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
JCCT		Lenexa	Kansas	66219	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Healthy volunteers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided