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A Phase 1, Randomized, Open-Label, 2-Part Study to Evaluate the Safety and Pharmacokinetics of ETR028 Acetate and ETR029 Acetate in Healthy Adult Subjects

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Trial Profile

A Phase 1, Randomized, Open-Label, 2-Part Study to Evaluate the Safety and Pharmacokinetics of ETR028 Acetate and ETR029 Acetate in Healthy Adult Subjects

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Sep 2024

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At a glance

  • Drugs ETR 028 (Primary) ; ETR 029 (Primary)
  • Indications Acute pain
  • Focus Adverse reactions; Pharmacokinetics; Proof of concept
  • Acronyms O2P-001
  • Sponsors Elysium Therapeutics

Most Recent Events

  • 03 Sep 2024 According to an Elysium Therapeutics media release, results from this trial presented at the PAINWeek 2024 being held September 3-6 in Las Vegas.
  • 23 Jul 2024 According to an Elysium Therapeutics media release, results from this trial will be presented at the PAINWeek 2024 being held September 3-6 in Las Vegas. The company look forward to discussing these results and and plans for progressing O2P hydrocodone to the next phase of clinical trials following discussions with the FDA.
  • 05 Mar 2024 According to an Elysium Therapeutics media release, company plan to meet with the FDA to discuss next steps, finalize dose form for remaining clinical studies, and seek partners and investors.

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