ENA-001 for Slow Breathing

Overseen By Mathews

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Enalare Therapeutics Inc.

Must not be taking: Antidepressants, Antianxiety, CYP450 inhibitors

Disqualifiers: Psychiatric disease, Alcohol abuse, Drug abuse, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called ENA-001, tested for its potential to address slow breathing. The trial aims to determine the drug's safety and how the body processes it when administered through an IV or muscle injection. Participants will receive either the actual treatment or a placebo (a harmless substance used for comparison). Suitable candidates for this trial are individuals without a history of breathing issues, such as asthma or sleep apnea, and with normal heart health. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any prescription or over-the-counter medications, including vitamins and supplements, at least 14 days before the screening. Additionally, you must avoid using certain enzyme-affecting drugs (CYP450 inhibitors/inducers) for 30 days before the screening.

Is there any evidence suggesting that ENA-001 is likely to be safe for humans?

Research shows that ENA-001 is generally safe and well-tolerated. Studies have demonstrated that ENA-001 can be administered in various amounts without causing major side effects. Most participants in these studies did not experience serious health problems when taking ENA-001.

Researchers tested the treatment to assess its impact on breathing, and it successfully increased breathing rates. This suggests it works effectively without causing harm. The trials focused on safety and tolerability, carefully monitoring participants for any adverse reactions.

In summary, previous studies have tested ENA-001 and found it safe, making it a promising option for treating slow breathing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for slow breathing, which often involve respiratory stimulants like doxapram or supportive measures such as mechanical ventilation, ENA-001 offers a novel approach. ENA-001 is unique because it's designed to be administered quickly via intravenous or intramuscular injection, potentially providing rapid relief. Researchers are excited about ENA-001 because it could offer a more immediate and direct way to tackle slow breathing, which might be especially beneficial in critical situations where time is of the essence.

What evidence suggests that ENA-001 might be an effective treatment for slow breathing?

This trial will evaluate ENA-001 for its effectiveness in treating slow breathing. Studies have shown that ENA-001 can effectively address slow breathing caused by various substances. For instance, it has improved slow or shallow breathing due to opioids. ENA-001 acts as a "breathing booster," increasing breathing rates without causing withdrawal symptoms. Early research suggests that ENA-001 may also help with breathing problems caused by anesthetics like propofol, making it a promising option for various breathing issues. Participants in this trial will receive either ENA-001 or a placebo to assess its efficacy. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals weighing between 50 to 100 kg with normal body temperature, blood pressure, pulse rate, and no significant lab abnormalities. They must have a BMI of 18-30 kg/m2, no signs of heart disease on an ECG, and liver enzymes within the normal range. Participants need to consent to the trial's procedures.

Inclusion Criteria

My weight is between 50 and 100 kg.

I am willing to sign consent and can follow the trial schedule.

My pulse rate is between 41 and 100 beats per minute.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single intravenous (IV) and intramuscular (IM) doses of ENA-001 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

22 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ENA-001

Trial Overview The study tests ENA-001's safety and effects when given as a single dose via IV or IM injection compared to a placebo. It aims to understand how the drug behaves in the body (pharmacokinetics) and its impact on opioid-induced respiratory issues (pharmacodynamics).

How Is the Trial Designed?

Group I: ENA-001 Treatment Arm Experimental Treatment 1 Intervention

ENA-001 for intravenous injection will be given over 3-5 seconds and will be administered via a suitable arm vein with an indwelling catheter. ENA-001 for intramuscular injection will be administered over 3-5 seconds via both deltoid muscles.

Group II: Placebo Treatment Arm Placebo Group 1 Intervention

Placebo for intravenous injection will be given over 3-5 seconds and will be administered via a suitable arm vein with an indwelling catheter. Placebo for intramuscular injection will be administered over 3-5 seconds via both deltoid muscles.

Who Is Running the Clinical Trial?

Enalare Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

200+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06967259

ENA-001 for Opioid Induced Respiratory Depression To determine the safety of single-dose safety of ENA-001 compared to placebo in healthy volunteers after Intravenous (IV) and Intramuscular (IM) injection.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9544529/

A Novel Agnostic Respiratory Stimulant as a Treatment for ... ENA-001 had the most dramatic effect on Vt, where a consistent rise was seen through the four hours (Figure 2A). Reported as Vt per kg of body ...

3. withpower.com withpower.com/trial/phase-1-respiratory-insufficiency-5-2025-e2f1a

ENA-001 for Slow Breathing Trial Overview The study tests ENA-001's safety and effects when given as a single dose via IV or IM injection compared to a placebo. It aims to understand how ...

4. investor.eagleus.com investor.eagleus.com/news-releases/news-release-details/eagle-pharmaceuticals-takes-equity-stake-option-acquire-enalare

News Details ENA-001 has the potential to treat respiratory depression associated with polysubstance abuse without inciting the withdrawal effect experienced ...

5. enalare.com enalare.com/wp-content/uploads/2022/01/Enalare-Overview-Long-Deck-NC-Jan-2022.pdf

Enalare Therapeutics Inc. Expected outcome highlights: • Demonstrate ENA-001 as a reversal agent for respiratory depression associated with propofol under hypoxic and hypercapnic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10977476/

A Single Ascending-Dose Study of the Safety, Tolerability ... ENA-001 was generally safe and well tolerated over the dose range studied (0.96 to 1.92 mg/kg/hour). ENA-001 was able to drive hyperventilation ...

7. cureus.com cureus.com/articles/314377-ena-001-reverses-xylazinefentanyl-combination-induced-respiratory-depression-in-rats-a-qualitative-pilot-study

ENA-001 Reverses Xylazine/Fentanyl Combination ... Xylazine exacerbates the respiratory depression induced by fentanyl. Because xylazine is a non-opioid, it is resistant to reversal by opioid ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38550433/

A Single Ascending-Dose Study of the Safety, Tolerability ... ENA-001 was generally safe and well tolerated over the dose range studied (0.96 to 1.92 mg/kg/hour). ENA-001 was able to drive hyperventilation ...