Trials / Active Not Recruiting
Active Not RecruitingNCT06967259
ENA-001 for Opioid Induced Respiratory Depression
A Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ENA-001 Administered as Intravenous (IV) and Intramuscular (IM) Doses
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Enalare Therapeutics Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-05-14
- Primary completion
- 2026-07-30
- Completion
- 2026-12-30
- First posted
- 2025-05-13
- Last updated
- 2025-12-30
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06967259. Inclusion in this directory is not an endorsement.