ENA-001 for Slow Breathing

Overseen By Mathews

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Enalare Therapeutics Inc.

Must not be taking: Antidepressants, Antianxiety, CYP450 inhibitors

Disqualifiers: Psychiatric disease, Alcohol abuse, Drug abuse, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

18 Participants Needed

Trial Summary

What is the purpose of 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 is for individuals weighing between 50 to 100 kg with normal body temperature, blood pressure, pulse rate, and no significant lab abnormalities. They must have a BMI of 18-30 kg/m2, no signs of heart disease on an ECG, and liver enzymes within the normal range. Participants need to consent to the trial's procedures.

Inclusion Criteria

My weight is between 50 and 100 kg.

I am willing to sign consent and can follow the trial schedule.

My pulse rate is between 41 and 100 beats per minute.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single intravenous (IV) and intramuscular (IM) doses of ENA-001 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

22 weeks

Treatment Details

Interventions

• ENA-001

Trial Overview The study tests ENA-001's safety and effects when given as a single dose via IV or IM injection compared to a placebo. It aims to understand how the drug behaves in the body (pharmacokinetics) and its impact on opioid-induced respiratory issues (pharmacodynamics).

Participant Groups

Group I: ENA-001 Treatment Arm Experimental Treatment 1 Intervention

ENA-001 for intravenous injection will be given over 3-5 seconds and will be administered via a suitable arm vein with an indwelling catheter. ENA-001 for intramuscular injection will be administered over 3-5 seconds via both deltoid muscles.

Group II: Placebo Treatment Arm Placebo Group 1 Intervention

Placebo for intravenous injection will be given over 3-5 seconds and will be administered via a suitable arm vein with an indwelling catheter. Placebo for intramuscular injection will be administered over 3-5 seconds via both deltoid muscles.

Who Is Running the Clinical Trial?

Enalare Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

200+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+