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NCT06967259 · ClinicalTrials.gov registry record · Phase 1
ENA-001 for Opioid Induced Respiratory Depression
A Phase 1 study of Respiratory Depression, sponsored by Enalare Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT06967259: Active Phase 1 study of Respiratory Depression, sponsored by Enalare Therapeutics.
NCT06967259 is a Phase 1 study of Respiratory Depression that is active but no longer recruiting, run by Enalare Therapeutics. The registered enrollment target is 36 participants, below the 42-participant average among 4 other Respiratory Depression trials with a reported enrollment target (14% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06967259, a Phase 1 study of Respiratory Depression, is active but no longer recruiting, sponsored by Enalare Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
To determine the safety of single-dose safety of ENA-001 compared to placebo in healthy volunteers after Intravenous (IV) and Intramuscular (IM) injection. Primary endpoints include the laboratory range values of safety laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis). Any measurement out of range will be assessed for adverse event.
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
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-05-14 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 1 |
What the registry record for NCT06967259 still lists
NCT06967259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 42-participant average among 4 other Respiratory Depression trials with a reported enrollment target (14% lower).
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.
NCT06967259 reports a single indexed study location in Kansas, New Jersey.
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.
What interventions are being tested in trial NCT06967259?
The interventions under investigation include: Placebo Comparator (DRUG), ENA-001 (DRUG).
Who is sponsoring clinical trial NCT06967259?
This trial is sponsored by Enalare Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
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