Actively Recruiting
ENA-001 for Opioid Induced Respiratory Depression
Led by Enalare Therapeutics Inc. · Updated on 2026-05-08
36
Participants Needed
3
Research Sites
85 weeks
Total Duration
On this page
Sponsors
E
Enalare Therapeutics Inc.
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
ENA-001 for Opioid Induced Respiratory Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide written informed consent and follow dose and visit schedules
- Male or female aged over 18 to 55 years
- Weigh between 50 and 100 kg
- Body Mass Index between 18 and 30 kg/m2
- No clinical or electrocardiographic signs of ischemic heart disease with normal cardiac intervals for gender
- Normal clinical laboratory tests including blood hematology, chemistry, coagulation, urinalysis and liver enzymes
- Vital signs within specified ranges (temperature, blood pressure, pulse rate) during screening and Day -1
- Men not vasectomized must agree to use effective contraception or abstain during and 3 months after the trial
- Women of childbearing potential must have negative pregnancy tests and agree to effective contraception or abstinence during and 3 months after dosing
- Women of non-childbearing potential must have undergone sterilization or be postmenopausal
- Normal Allen's test for both hands
- Free of any clinically significant disease that would interfere with study evaluations
You will not qualify if you...
- Current psychiatric disease requiring daily medication or recent depressive disorders
- Generalized Anxiety Disorder requiring treatment
- History of alcohol abuse exceeding two drinks per day in past two years
- History of drug abuse in past two years
- Regular smoking/vaping or nicotine use more than 5 times per week in past year
- Positive drug or alcohol tests at screening
- Positive for HIV, Hepatitis B or C
- Recent blood or plasma donation
- History of bleeding disorders or coagulopathies
- History of respiratory diseases such as asthma, tuberculosis, COPD, sleep apnea
- Participation in other investigational drug studies recently
- History of moderate to severe motion sickness
- Unwillingness to remove facial hair for mask sealing
- Any condition affecting drug distribution, metabolism, or excretion including liver, pancreas, kidney diseases
- Recent infectious disease affecting participation
- Study staff personnel or their family members
- Allergic reactions interfering with participation
- History of malignancy in remission less than 5 years
- Personal or family history of malignant hyperthermia or arrhythmias
- High daily consumption of caffeine or energy drinks
- Allergy to lidocaine or similar local anesthetics
- History of radial artery disease or difficult arterial line placement
- Difficult airway access or certain digestive disorders
- Use of medications affecting drug metabolism within specified timeframes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
South Florida Research Phase I-IV
Miami, Florida, United States, 33166
Actively Recruiting
2
Dr. Vince Clinical Research
Overland Park, Kansas, United States, 66212
Completed
3
Clinilabs
Eatontown, New Jersey, United States, 07724
Active, Not Recruiting
Research Team
M
Mathews
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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