ENA-001 for Post Operative Respiratory Depression (PORD)

NCT06137638 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ENA-001-201
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Respiratory Depression

Outcome Measures

Primary Outcomes (1)

• 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

  To evaluate the effect of ENA-001 on pulmonary ventilation following extubation/airway removal up to two hours beyond cessation of treatment. Endpoint is arterial CO2 tension (PaCO2)

  2 hours

Study Arms (2)

ENA-001 Treatment Arm

EXPERIMENTAL

ENA-001 consisting of 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.

Drug: ENA-001

Placebo Treatment Arm

PLACEBO COMPARATOR

Matching placebo for ENA-001 will consist of the solution that is used as diluent for ENA-001. Placebo will be administered similarly consisting of 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.

Drug: ENA-001

Interventions

ENA-001 DRUG

ENA-001 will be prepared in Ringer's lactate solution. A loading dose will be administered for 20 minutes followed by continuous infusion until the patient meets the criteria for PACU discharge (≥ 9 Aldrete score) or ABG reveals PaCO2 \< 30 mmHg with pH in the normal range. ENA-001 is for IV injection ready for use per subject by the investigational pharmacy, according to the randomization schedule.

ENA-001 Treatment Arm; Placebo Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;amp;lt; 450 msec QTcF males \&amp;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:
• body temperature, ≥35.5°C to ≤37.5°C
• systolic blood pressure, ≥90 to ≤150 mm Hg
• diastolic blood pressure, ≥50 to ≤95 mm Hg
• pulse rate, ≥40 to ≤100 bpm
• Non-vasectomized men must agree to use a condom with spermicide, double-barrier contraception, abstain from heterosexual intercourse, or have a sole-sexual partner of non childbearing potential during the trial and for 3 months after stopping the medication. Male subjects must agree not to donate sperm from the time of dosing until 90 days after dosing.
• Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative pregnancy test prior to enrolment and must agree to the following contraception requirements from screening through 3 months after dosing of the study drug:
• Be sexually inactive (abstinent)

You may not qualify if:

• 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.
• 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.
• Current or recent presentation of clinically significant of dyspnea, asthma, tuberculosis, chronic obstructive pulmonary disease, sleep apnea (central or obstructive) or any other ventilatory / lung disease.
• Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening.
• History of moderate to severe motion sickness.
• Subjects who are unwilling to remove excessive facial hair preventing sealing of the occlusive face mask.
• Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study.
• Any surgical or medical condition which might significantly alter the distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following, and be discussed with the sponsor prior to enrollment into the trial:
• history of pancreatic injury or pancreatitis;

Sponsors & Collaborators

• Enalare Therapeutics Inc.: lead

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Mathews

CONTACT

9089475491; jmathews@enalare.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start (Estimated): December 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share