Healthy Volunteer - CompletePhase 1NCT07180420
Proof of Concept (PoC) Evaluation of Naloxone Unique Intramuscular (IM) Injection
A Phase 1 study testing naloxone IM in people with Healthy Volunteer - Complete, run by STAT Therapeutics Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer - Complete
- What is being tested?
- naloxone IM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2024to 8 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Healthy Volunteer - Complete
- Being tested
- naloxone IM
- Keywords
- naloxone intramuscular forearm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naloxone IMDrug
naloxone IM to the EDC/forearm muscle
| Study group | Role | What they receive |
|---|---|---|
| Naloxone intramuscular (IM) | Experimental | intramuscular (IM) to extensor digitorum communis (EDC)/forearm muscle Receives: Drug: naloxone IM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Profile (area under the curve AUC)
Area under the Curve (AUC)
Measured: 1 day
Secondary outcomes (1)
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))
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start24 Mar 2024
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteer - CompleteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study was an outpatient, open-label, single period, single treatment, single dose proof of concept (PoC) trial in 12 healthy volunteers
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- STAT Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson County ClinTrials
- Responsible party
- Sponsor
- Investigators
- Thomas Krol, PharmD, Study chair, STAT Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180420
- Sponsor's protocol ID
- STAT501-01
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Healthy volunteers
Publications
Krol TF, Beutel BG, Fierro C, Weir SJ. The Dorsal Forearm as a Novel Target for Intramuscular Injections: Clinical Pharmacokinetic Results With Naloxone. Clin Transl Sci. 2025 Nov;18(11):e70397. doi: 10.1111/cts.70397.
PubMed 41236169
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept (PoC) Evaluation of Naloxone Unique Intramuscular (IM) Injection
- ClinicalTrials.gov ID
- NCT07180420
- Acronym / sponsor ID
- STAT501-01
- Conditions
- Healthy Volunteer - Complete
- Keywords
- naloxone intramuscular forearm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- STAT Therapeutics IncIndustry (pharma, biotech, devices)
- Collaborators
- Johnson County ClinTrials
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study was an outpatient, open-label, single period, single treatment, single dose proof of concept (PoC) trial in 12 healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| Naloxone intramuscular (IM) | Experimental | Drug: naloxone IMintramuscular (IM) to extensor digitorum communis (EDC)/forearm muscle |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naloxone IMnaloxone IM to the EDC/forearm muscle | Drug | Naloxone intramuscular (IM) |
Primary outcome
Pharmacokinetic Profile (area under the curve AUC)
Time frame: 1 day
Area under the Curve (AUC)
1 secondary outcome
PK Profile (Cmax, Tmax, T/2- half-life)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Derived from this study: PubMed 41236169Krol TF, Beutel BG, Fierro C, Weir SJ. The Dorsal Forearm as a Novel Target for Intramuscular Injections: Clinical Pharmacokinetic Results With Naloxone. Clin Transl Sci. 2025 Nov;18(11):e70397. doi: 10.1111/cts.70397.
- Individual participant dataSharing planned: Undecided. Healthy volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Krol, PharmD study chair
STAT Therapeutics Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing naloxone IM in people with Healthy Volunteer - Complete, run by STAT Therapeutics Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Profile (area under the curve AUC) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07180420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.