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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: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 06 Oct 2025

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At a glance

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

Most Recent Events

  • 06 Aug 2025 According to an Entrada Therapeutics media release,The study received authorization in the U.K. (March 2025) and EU (May 2025).The Company expects to report data from Cohort 1 (5 mg/kg) in mid-2026, with data from Cohort 2 and Cohort 3 (up to 15 mg/kg) to follow.
  • 06 Aug 2025 According to an Entrada Therapeutics media release, dosing of first patient from this study is expected in Q3 2025.Also Multiple clinical trial sites in U.K. and EU for this trial.
  • 26 Jun 2025 Status changed from planning to not yet recruiting.

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