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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 16, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06967259). This is a study registration, not published results. Lead sponsor: Enalare Therapeutics Inc.. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 62 participants (ACTUAL). Conditions: Respiratory Depression. Interventions: DRUG: ENA-001; DRUG: Placebo Comparator. Primary outcome measures: Range values of laboratory tests (Safety) , From screening to follow up visit (approx. 8 weeks); Range values of special chemistry tests (Safety) , From screening to follow up visit (approx. 8 weeks); Vital Sign measurements (Safety and tolerability) , From screening to follow up visit (approx. 8 weeks); Measurement of ECG parameters (Safety and tolerability) , From screening to follow up visit (approx. 8 weeks); Complete Physical Exam Findings (Safety and tolerability) , From screening to follow up visit (approx. 8 weeks); Incidence of Adverse Events (Safety and tolerability) , From screening to follow up visit (approx. 8 weeks). Brief 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.