ENA-001 for Opioid Induced Respiratory Depression

Conditions

• Respiratory Depression

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• ENA-001 — DRUG
  Concentration for ENA-001 IV formulation is 10 mg/mL. Concentration for ENA 001 IM formulation is 30 mg/mL.
• Placebo Comparator — DRUG
  Placebo comes in 5 mL/vial. Placebo matches ENA-001 injection; however, no ENA-001 is included.

Study Details

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.

Key Dates

Start date

May 14, 2025

Status verified

Jun 2025

Primary completion

Jul 30, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: ENA-001 Treatment Arm
  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.
• Placebo Comparator: Placebo Treatment Arm
  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.

Primary Outcome Measure

Range values of laboratory tests (Safety) [ Time Frame: From screening to follow up visit (approx. 8 weeks) ]

Central Contacts

• Mathews
  908-947-5491
  [email protected]

Locations (3)

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