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New nalmefene study could speed up opioid overdose rescue

NCT ID NCT07543276

Knowledge-focused Sponsor: Knoa Pharma LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested how a new form of nalmefene (a drug that reverses opioid overdoses) behaves in the body when given as a shot or through an IV. 13 healthy adults received single doses of both the new and standard versions. The goal was to see how quickly the drug reaches the bloodstream, which could help make overdose treatments faster and more effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Started

Feb 2026

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion criteria: 1. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. 2. Body weight ranging from 50 to 100 kg (110-220 lbs) inclusive at screening and body mass index (BMI) within the range \[18.0-30.0\] kg/m2 (inclusive). 3. Willing to be compliant with the protocol, are able to read, understand, and answer verbal questions. Key Exclusion criteria: 1. Females who are pregnant or lactating. 2. Current or recent (within 5 years) history of drug or alcohol abuse. 3. History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion. 4. Known allergy or hypersensitivity to nalmefene hydrochloride or any of the excipients or other drug product components of nalmefene hydrochloride. 5. Dosing in a clinical drug study during the 30 days preceding the initial dose in this study. 6. Any significant illness during the 30 days preceding the initial dose in this study Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

acute opioid poisoning Opiate Overdose

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid overdose

Contacts and locations

Locations

  • Ohio Clinical Trials

    Columbus, Ohio, 43212, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.