NCT06137638

ENA-001 for Post Operative Respiratory Depression (PORD)

A Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Efficacy of ENA-001 in Preventing Postoperative Respiratory Depression

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Enalare Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	ENA-001	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.

Timeline

• Start date: 2026-12-15
• Primary completion: 2027-06-15
• Completion: 2027-07-15
• First posted: 2023-11-18
• Last updated: 2026-02-27

Regulatory

• FDA-regulated drug study