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New treatment option for Respiratory Depression
Official title ENA-001 for Opioid Induced Respiratory Depression
ClinicalTrials.gov ID: NCT06967259
What this study is testing
What is ENA-001?
ENA-001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for respiratory depression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- people 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.
- people must have Body Mass Index [weight/height2 (kg/m2)] between 18 to 30 kg/m2 (inclusive).
- Have no clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator with normal cardiac intervals appropriate...
You likely can't join if
- Current diagnosis of psychiatric disease requiring daily medication, including controlled or uncontrolled schizophrenia and current or recently...
- 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.
- History of regular smoking/vaping or any use of nicotine products within the past year (\>5 per week means exclusion).
- Failure to take or test positive of the drug of abuse tests or alcohol urine test at screening or check-in.
See the full eligibility criteria
Who can join
- people 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.
- people must have Body Mass Index [weight/height2 (kg/m2)] between 18 to 30 kg/m2 (inclusive).
- Have no clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator with normal cardiac intervals appropriate for their gender. The Screening 12 lead electrocardiogram (ECG)...
- people' clinical laboratory tests (blood hematology, blood chemistry, coagulation and urinalysis and liver enzymes must be in normal range. Where applicable, normal range is defined as in the FDA guidance Toxicity...
- Vital sign measurements must be within the following ranges during screening and on Day -1:
- body temperature, \>35.5 C to ≤37.5 C
- systolic blood pressure, \>90 to ≤140 mmHg
- diastolic blood pressure, \>40 to ≤95 mmHg
- pulse rate, \>55 to ≤100 bpm
- Non-vasectomized men must agree to use a condom with spermicide (when marketed in the country), double-barrier contraception, abstain from heterosexual intercourse, or have a sole sexual partner of non-childbearing...
- Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative pregnancy test prior to enrollment as well as...
- Be sexually inactive (abstinent)
- Hormonal or non-hormonal intrauterine device in place for at least 3 months prior to dosing with a barrier method (condom or diaphragm) and spermicide at least 3 months after last dose of study drug.
- Double barrier methods (e.g., condom and diaphragm) with spermicide for at least 30 days prior to screening and through at least 3 months after last dose of study drug. Hormonal oral contraception + use of condoms and...
- Surgical sterilization of the partner (vasectomy at least six months prior to dosing) with a barrier method (e.g., condom or diaphragm) and spermicide through at least 3 months after last dose of study drug.
- Female people who claim to be sexually inactive but become sexually active during the course of the study must agree to use a double barrier method (e.g., condom and diaphragm) with spermicide from the time of the start...
- Hysteroscopic sterilization and using a barrier method (e.g., condom or diaphragm) and spermicide throughout the study.
- Bilateral tubal ligation or bilateral salpingectomy and be using a barrier method (e.g., condom or diaphragm) and spermicide throughout the study.
- Hysterectomy.
- Bilateral oophorectomy.
- Women with amenorrhea for at least 1 year prior to dosing and who have follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status, are considered post-menopausal and therefore of non...
- people must demonstrate a normal Allen's test for both hands, to assure adequate arterial collateral circulation.
- people must be free of any clinically significant disease that would interfere with the study evaluations.
What rules you out
- 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.
- History of regular smoking/vaping or any use of nicotine products within the past year (\>5 per week means exclusion).
- Failure to take or test positive of the drug of abuse tests or alcohol urine test at screening or check-in.
- Positive for HIV, or Hepatitis B or C at screening.
- Blood donation or blood loss within 60 days of screening or plasma donation within 7 days of screening.
- people with a history of bleeding disorders or coagulopathies.
- History of dyspnea, asthma, tuberculosis, chronic obstructive pulmonary disease, sleep apnea or any other ventilatory / lung disease.
- Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening.
- History of moderate to severe motion sickness.
- people who are unwilling to remove excessive facial hair preventing sealing of the occlusive face mask.
- people who, in the opinion of the investigator, will not be able to participate optimally in the study.
- Any surgical or medical condition which might significantly alter the distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following, and be discussed with the...
- history of pancreatic injury or pancreatitis;
- history or presence of liver disease or liver injury;
- history of previously elevated ALT/AST values;
- history or presence of impaired renal function as indicated by clinically significant elevation in creatinine, BUN/urea, urinary albumin, or clinically significant urinary cellular constituents; or
- history of urinary obstruction or difficulty in voiding.
- Subject who has a history of any infectious disease within 4 weeks prior to drug administration that in the opinion of the investigator, affects the subject's ability to participate in the trial.
- people who are part of the study staff personnel or family members of the study staff personnel.
- people who have demonstrated allergic reactions (e.g., food, drug, atopic reactions, or asthmatic episodes) which, in the opinion of the investigator and Sponsor, interfere with their ability to participate in the trial.
- people who have a history of malignancy and are in remission \<5 years.
- Personal or family history of malignant hyperthermia.
- Personal or family history of arrhythmias or ECG conductance abnormalities.
- people with an average daily consumption of a large quantity of coffee, tea, (\> 6 cups per day), energy drinks, or equivalent.
- people with a known history of allergy to lidocaine, xylocaine, or other local anesthetic agents.
- people with any history of radial-artery (in either arm) disease or injury, or prior known difficulty with placement of arterial line cannula.
- people with history of known difficult airway access and presence of a "nonreassuring" airway exam (as determined by the investigator), gastroesophageal reflux disease, gastric motility disorders, or delayed gastric...
- Use of any prescription or over-the-counter medications (such as antacids, vitamins, minerals, dietary/herbal preparations, St. John's Wort, and nutritional supplements) within 14 days prior to Screening; and use of...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Overland Park, Kansas, United States
- Eatontown, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Overland Park, Kansas, United States; Eatontown, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.