ENA-001 for Opioid Induced Respiratory Depression
This study is testing a new drug called ENA-001, given either through a vein (intravenous or IV) or as a shot into a muscle (intramuscular or IM). The main goal is to see if ENA-001 is safe and how well your body handles it. Researchers will also look at how the drug moves through your body and what effects it has. This study is for people aged 18 to 55 who weigh between 50 and 100 kg and have a Body Mass Index (BMI) between 18 and 30. The study will enroll 36 participants. Success in this study means understanding the safety and how the body processes ENA-001. The current recruitment status is unclear.
- Study design
- This is a Phase I interventional study, meaning it's an early-stage trial to test a new treatment. It involves comparing ENA-001 to a placebo (an inactive substance that looks like the study drug).
- What's involved
- You would need to be willing to give written informed consent and follow the dose and visit schedules. The study involves safety tests like laboratory tests, special chemistry tests, and vital sign measurements.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for approximately 8 weeks after screening for safety measurements.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ENA-001 for Opioid Induced Respiratory Depression
At a glance
Conditions
Where it's being run
3 sites across 3 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Range values of laboratory tests (Safety)From screening to follow up visit (approx. 8 weeks)
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.
- Range values of special chemistry tests (Safety)From screening to follow up visit (approx. 8 weeks)
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 special chemistry assessments (Ca+2 and HCO3- or venous CO2). Any measurement out of range will be assessed for adverse event.
- Vital Sign measurements (Safety and tolerability)From screening to follow up visit (approx. 8 weeks)
To determine the single-dose safety and tolerability of ENA-001 compared to placebo in healthy volunteers after Intravenous (IV) and Intramuscular (IM) injection. Primary endpoints include vital sign measurements (blood pressure and heart rate). Any measurement out of range may indicate an adverse event, meet stopping criteria, and/or indicate intolerability of ENA-001. Systolic and diastolic blood pressure (mmHg), pulse rate (HR), body temperature (°C) will be graded according to the FDA guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
- Measurement of ECG parameters (Safety and tolerability)From screening to follow up visit (approx. 8 weeks)
To determine the safety and tolerability of single-dose safety of ENA-001 compared to placebo in healthy volunteers after Intravenous (IV) and Intramuscular (IM) injection. Primary endpoints include ECG measurement. Any measurement out of range may indicate an adverse event and/or indicate intolerability of ENA-001.
- Complete Physical Exam Findings (Safety and tolerability)From screening to follow up visit (approx. 8 weeks)
To determine the safety and tolerability of single-dose safety of ENA-001 compared to placebo in healthy volunteers after Intravenous (IV) and Intramuscular (IM) injection. Primary endpoints include physical examination findings. Complete physical examination will include: head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, and neurological exam. Any post-baseline findings of the physical examination will be assessed for adverse event.
- Incidence of Adverse Events (Safety and tolerability)From screening to follow up visit (approx. 8 weeks)
To determine the safety and tolerability of single-dose safety of ENA-001 compared to placebo in healthy volunteers after Intravenous (IV) and Intramuscular (IM) injection. Number of participant with adverse events and grade of AEs will be used to inform on safety and tolerability of ENA-001.