ENA-001 for Opioid Induced Respiratory Depression
ConditionRespiratory Depression
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorEnalare Therapeutics Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedules.
Male and female, >18 to ≤55 years of age.
Subject must weigh ≥50 to ≤100 kg.
Subjects must have Body Mass Index [weight/height2 (kg/m2)] between 18 to 30 kg/m2 (inclusive).
Disqualifiers
Current diagnosis of psychiatric disease requiring daily medication, including controlled or uncontrolled schizophrenia and current or recently treated depressive disorders.
Current diagnosis of Generalized Anxiety Disorder (DSM-5) requiring treatment.
History of alcohol abuse (more than an average of two (2) drinks per day) within the past two (2) years.
History of drug abuse within the past two years.
Trial design
Design model
Sequential
Treatments tested in this trial
ENA-001
DrugConcentration for ENA-001 IV formulation is 10 mg/mL. Concentration for ENA 001 IM formulation is 30 mg/mL.
Placebo Comparator
DrugPlacebo comes in 5 mL/vial. Placebo matches ENA-001 injection; however, no ENA-001 is included.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: ENA-001 Treatment ArmExperimental treatment 1 intervention
Group B: Placebo Treatment ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Range values of laboratory tests (Safety)
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.
Time frame
From screening to follow up visit (approx. 8 weeks)2
Range values of special chemistry tests (Safety)
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.
Time frame
From screening to follow up visit (approx. 8 weeks)3
Vital Sign measurements (Safety and tolerability)
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.
Time frame
From screening to follow up visit (approx. 8 weeks)4
Measurement of ECG parameters (Safety and tolerability)
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.
Time frame
From screening to follow up visit (approx. 8 weeks)Secondary outcomes
1
Evaluation of spirometry values (PD)
To evaluate the single dose pharmacodynamics (PD) of ENA-001 in healthy volunteers after IV and IM dosing. PD will include spirometric measurement for precision in determination of tidal volume (Vt) and respiratory rate (f), which will calculate minute ventilation (MV). These measures are secondary endpoint insomuch as an improvement in ventilation can be seen without a concomitant increase in MV.
Time frame
Each dosing day (Day 1) - Approximately 3 weeks2
Evaluation of capnography values (PD)
To evaluate the single dose pharmacodynamics (PD) of ENA-001 in healthy volunteers after IV and IM dosing. End-tidal carbon dioxide (ETCO2) reflects the production, transportation, and elimination of CO2. ETCO2 will be monitored by capnography using a suitable patient interface such as a dual O2 delivery and CO2 monitoring cannula. ETCO2 value will be used to determine stopping criteria.
Time frame
Each dosing day (Day 1) - Approximately 3 weeks3
Evaluation of Pulse Oximetry (PD)
Pulse oximetry: hemoglobin saturation (SpO2) and pulse rate (PR) will determine arterial hemoglobin saturation level in a tissue bed that is reflective of arterial saturation. Continuous decrease in SpO2 and participant will not increase to next dose level.
Time frame
Each dosing day (Day 1) - Approximately 3 weeks4
Evaluation of ABG measurements (PD)
To evaluate the single dose pharmacodynamics (PD) of ENA-001 in healthy volunteers after IV and IM dosing. Arterial Blood Gases (ABG) values will be used to assess the effectiveness of ventilation. ABG values are precise indicators for interpreting effectiveness of ventilation (pH and PaCO2). ABGs provide ventilation-related data which are independent of minute ventilation (MV). Persistent hyperventilation and associated hypocarbia not relieved by rebreathing exhaled CO2 will be considered a Serious Adverse Event (SAE) and a study stopping criteria.
Time frame
Each dosing day (Day 1) - Approximately 3 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Enalare Therapeutics Inc.
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov