Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT07180420
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2025-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Proof of Concept (PoC) Evaluation of Naloxone Unique Intramuscular (IM) Injection
Sponsor:
STAT Therapeutics Inc
Organization:
Study Overview
Official Title:
Proof of Concept (PoC) Evaluation of Naloxone Unique Intramuscular (IM) Injection
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: