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ENA-001 for Opioid Induced Respiratory Depression | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

ENA-001 for Opioid Induced Respiratory Depression

A Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ENA-001 Administered as Intravenous (IV) and Intramuscular (IM) Doses

NCT06967259•Enalare Therapeutics Inc.

View on ClinicalTrials.gov

Summary

This study is a Phase I clinical trial to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profiles with single intravenous (IV) and intramuscular (IM) doses of ENA-001.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedules.
•2. Male and female, \>18 to ≤55 years of age.
•3. Subject must weigh ≥50 to ≤100 kg.
•4. Subjects must have Body Mass Index \[weight/height2 (kg/m2)\] between 18 to 30 kg/m2 (inclusive).
•5. Have no clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator with normal cardiac intervals appropriate for their gender. The Screening 12 lead electrocardiogram (ECG) conduction intervals must be within gender specific normal range (e.g., QTcf female \< 450 msec QT corrected for heart rate by Fridericia's cube root formula (QTcF) males \< 430 msec, PR interval ≤ 220 msec). ECGs are to be judged by the investigator or sub-investigator as per standardized procedures.
•6. Subjects' clinical laboratory tests (blood hematology, blood chemistry, coagulation and urinalysis and liver enzymes must be in normal range. Where applicable, normal range is defined as in the FDA guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials.
•7. Vital sign measurements must be within the following ranges during screening and on Day -1:
•1. body temperature, \>35.5 C to ≤37.5 C
•2. systolic blood pressure, \>90 to ≤140 mmHg
•3. diastolic blood pressure, \>40 to ≤95 mmHg
+17 more criteria

Exclusion Criteria

•1. Current diagnosis of psychiatric disease requiring daily medication, including controlled or uncontrolled schizophrenia and current or recently treated depressive disorders.
•2. Current diagnosis of Generalized Anxiety Disorder (DSM-5) requiring treatment.
•3. History of alcohol abuse (more than an average of two (2) drinks per day) within the past two (2) years.
•4. History of drug abuse within the past two years.
•5. History of regular smoking/vaping or any use of nicotine products within the past year (\>5 per week means exclusion).
•6. Failure to take or test positive of the drug of abuse tests or alcohol urine test at screening or check-in.
•7. Positive for HIV, or Hepatitis B or C at screening.
•8. Blood donation or blood loss within 60 days of screening or plasma donation within 7 days of screening.
•9. Subjects with a history of bleeding disorders or coagulopathies.
•10. History of dyspnea, asthma, tuberculosis, chronic obstructive pulmonary disease, sleep apnea or any other ventilatory / lung disease.
+21 more criteria

Locations (2)

Dr. Vince Clinical Research

Overland Park, Kansas, United States

Clinilabs

Eatontown, New Jersey, United States

Key Dates

Start Date

May 14, 2025

Primary Completion Date

July 30, 2026

Completion Date

December 30, 2026

Last Updated

December 30, 2025

Enrollment

ESTIMATED participants

Conditions

Respiratory Depression

Interventions

ENA-001

DRUG

Placebo Comparator

DRUG

Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

NCT06777758

Postoperative ComplicationsRespiratory Depression+3 more

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RECRUITINGNA

Effect of Percutaneous Electrical Acupoint Stimulation on the Improvement of Incidence of Adverse Respiratory Events

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ExtubationRespiratory Depression+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ENA-001 for Opioid Induced Respiratory Depression

Inclusion Criteria

Exclusion Criteria

Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

Effect of Percutaneous Electrical Acupoint Stimulation on the Improvement of Incidence of Adverse Respiratory Events

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