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ENA-001 for Opioid Induced Respiratory Depression

NCT06967259 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Respiratory Depression

Interventions

DRUG

ENA-001

Concentration for ENA-001 IV formulation is 10 mg/mL. Concentration for ENA 001 IM formulation is 30 mg/mL.

DRUG

Placebo Comparator

Placebo comes in 5 mL/vial. Placebo matches ENA-001 injection; however, no ENA-001 is included.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Enalare Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-14
Primary Completion
2026-07-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06967259 on ClinicalTrials.gov