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ENA-001 for Opioid Induced Respiratory Depression (NCT06967259) | Clinical Trial Compass

RecruitingPhase 1

ENA-001 for Opioid Induced Respiratory Depression

United States36 participantsStarted 2025-05-14

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedules.
✓. Male and female, \>18 to ≤55 years of age.
✓. Subject must weigh ≥50 to ≤100 kg.
✓. Subjects must have Body Mass Index \[weight/height2 (kg/m2)\] between 18 to 30 kg/m2 (inclusive).
✓. 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.
✓. 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.
✓. Vital sign measurements must be within the following ranges during screening and on Day -1:
✓. body temperature, \>35.5 C to ≤37.5 C

Exclusion criteria

✕. Current diagnosis of psychiatric disease requiring daily medication, including controlled or uncontrolled schizophrenia and current or recently treated depressive disorders.
✕. Current diagnosis of Generalized Anxiety Disorder (DSM-5) requiring treatment.
✕. History of alcohol abuse (more than an average of two (2) drinks per day) within the past two (2) years.
✕. History of drug abuse within the past two years.
✕. History of regular smoking/vaping or any use of nicotine products within the past year (\>5 per week means exclusion).
✕. Failure to take or test positive of the drug of abuse tests or alcohol urine test at screening or check-in.
✕. Positive for HIV, or Hepatitis B or C at screening.
✕. Blood donation or blood loss within 60 days of screening or plasma donation within 7 days of screening.

What they're measuring

1

Range values of laboratory tests (Safety)

Timeframe: From screening to follow up visit (approx. 8 weeks)

2

Range values of special chemistry tests (Safety)

Timeframe: From screening to follow up visit (approx. 8 weeks)

3

Vital Sign measurements (Safety and tolerability)

Timeframe: From screening to follow up visit (approx. 8 weeks)

4

Measurement of ECG parameters (Safety and tolerability)

Timeframe: From screening to follow up visit (approx. 8 weeks)

5

Complete Physical Exam Findings (Safety and tolerability)

Timeframe: From screening to follow up visit (approx. 8 weeks)

6

Incidence of Adverse Events (Safety and tolerability)

Timeframe: From screening to follow up visit (approx. 8 weeks)

Trial details

NCT IDNCT06967259

SponsorEnalare Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-30

Contact for this trial

Mathews

908-947-5491 jmathews@enalare.com

View on ClinicalTrials.gov More Respiratory Depression trials