Status:
COMPLETED
Proof of Concept (PoC) Evaluation of Naloxone Unique Intramuscular (IM) Injection
Lead Sponsor:
STAT Therapeutics Inc
Collaborating Sponsors:
Johnson County ClinTrials
Conditions:
Healthy Volunteer - Complete
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07180420
Start Date
March 24 2024
End Date
April 8 2024
Last Update
September 18 2025
Active Locations (1)
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1
JCCT
Lenexa, Kansas, United States, 66219