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ACTIVE NOT RECRUITING Phase 1

ENA-001 for Opioid Induced Respiratory Depression

NCT06967259 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Placebo Comparator
  • DRUG ENA-001

Study Locations (2)

Kansas

  • Dr. Vince Clinical Research — Overland Park

New Jersey

  • Clinilabs — Eatontown

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2025-05-14
Est. Completion 2026-12-30
Phase Phase 1

Sponsor

Enalare Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06967259

The ClinicalTrials.gov registry entry for NCT06967259 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Enalare Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Respiratory Depression appearing as the primary indexed condition, and to 2 interventions — of which Placebo Comparator is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06967259 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Kansas, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06967259 about?

NCT06967259 is a clinical study titled "ENA-001 for Opioid Induced Respiratory Depression". 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.

What is the current status of trial NCT06967259?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2025-05-14. Estimated completion is 2026-12-30.

What conditions does trial NCT06967259 study?

This clinical trial studies the following conditions: Respiratory Depression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06967259?

The interventions under investigation include: Placebo Comparator (DRUG), ENA-001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06967259?

This trial is sponsored by Enalare Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06967259 being conducted?

This trial has 2 study locations across Kansas, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial