Not Yet RecruitingPhase 2

ENA-001 for Post Operative Respiratory Depression (PORD)

200 participantsStarted 2026-12-15

Plain-language summary

This study is a Phase II, randomized, placebo-controlled, double-blind trial in 200 subjects having general anesthesia for major elective surgery with postoperative pain management to evaluate the efficacy, safety and tolerability of ENA-001 as a therapy to prevent post operative respiratory depression.

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

Inclusion criteria

✓. Willing to give written informed consent for the trial and willing/able to adhere to study procedures.
✓. Scheduled to undergo a major elective surgery, including abdominal, laparoscopic, nephrology, thoracic (non-cardiac), orthopedic (e.g., shoulder and ankle surgery), where the subject will be transferred to recover in the general postanesthesia recover unit (PACU) and extubation will be performed in the operating room or PACU.
✓. Undergoing surgical procedure with a intraoperative requirement of ≥ 250 µg of fentanyl; Enrolled base on expected pain management to necessitate ≥ 250 µg of fentanyl intraoperatively.
✓. Male and female, ≥18 years of age.
✓. American Society of Anesthesiologists (ASA) physical status classification 1-3.
✓. Have no clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator. The Screening 12 lead ECG conduction intervals must be within gender specific normal range (e.g., QTcF female \&amp;amp;lt; 450 msec QTcF males \&amp;amp;lt; 430 msec, PR interval ≤ 220 msec). ECGs are to be judged by the investigator or sub-investigator as per standardized procedures.
✓. Clinical laboratory tests (blood hematology, blood chemistry, coagulation and urinalysis) must not include any significant clinical abnormalities.
✓. Vital sign measurements must be within the following ranges during screening and on the day of dosing:

Exclusion criteria

✕. Ongoing treatment for a pre-existing chronic pain condition
✕. Use of an epidural / spinal block / major nerve block for the surgical procedure
✕. Surgical procedure that may interfere with the collection of data under the study protocol, such as craniofacial surgery which may impact the placement of a face mask for pulmonary function measurements.
✕. Current diagnosis of psychiatric disease, including anxiety disorder, that is uncontrolled and/or restricting normal daily function.
✕. History of alcohol abuse (more than an average of 2-drinks per day) within the past 2 years.
✕. History of drug abuse within the past 2 years.
✕. History of regular smoking within the past year (\&gt;5 per week means exclusion).
✕. Positive for HIV, or Hepatitis B or C at screening.

What they're measuring

To evaluate the effects of ENA-001 on pulmonary ventilation when administered to 100 subjects via continuous infusion of a loading dose of 2.0 mg/kg/hr for 20 minutes followed by a maintenance dose of 1.1 mg/kg/hr

Timeframe: 2 hours

Trial details

NCT IDNCT06137638

SponsorEnalare Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-15

Contact for this trial

Mathews

9089475491 jmathews@enalare.com

View on ClinicalTrials.gov More Respiratory Depression trials