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A 2-Part, Randomized, Double-Blind, Placebo-Controlled Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon 45 Skipping With an Initial Multiple Ascending Dose Part A to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ENTR-601-45, Followed by Part B to Evaluate the Safety and Efficacy of ENTR-601-45 (ELEVATE-45)

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Trial Profile

A 2-Part, Randomized, Double-Blind, Placebo-Controlled Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon 45 Skipping With an Initial Multiple Ascending Dose Part A to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ENTR-601-45, Followed by Part B to Evaluate the Safety and Efficacy of ENTR-601-45 (ELEVATE-45)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Sep 2026

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At a glance

  • Drugs ENTR 601 45 (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions; First in man
  • Acronyms ELEVATE-45
  • Sponsors Entrada Therapeutics

Most Recent Events

  • 05 Aug 2026 According to an Entrada Therapeutics media release, the Company expects to report data from the Cohort 1 MAD (5 mg/kg) in October 2026, data from the Cohort 2 MAD (10 mg/kg) in the first half of 2027, and data from Cohort 3 (up to 15 mg/kg) will follow, if needed.
  • 05 Aug 2026 According to an Entrada Therapeutics media release, company has completed enrollment and dosing of Cohort 1 part and cohort 2 dosing at 10 mg/kg is ongoing.
  • 02 Jun 2026 According to an Entrada Therapeutics media release, participants in cohort 1 have advanced to the open-label phase 2 portion of the trial.

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