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
Qualifiers
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
Treatments tested in this trial
- ENA-001
- Placebo Comparator
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Enalare Therapeutics Inc.
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov