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

STAT Therapeutics Inc

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer - Complete

Treatments: Drug: naloxone IM

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07180420

STAT501-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Naloxone intramuscular (IM)

Experimental group

Description:

intramuscular (IM) to extensor digitorum communis (EDC)/forearm muscle

Treatment:

Drug: naloxone IM