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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 II

Latest Information Update: 22 Dec 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 Nov 2025 According to an Entrada Therapeutics media release, status changed from not yet recruiting to recruiting.
  • 06 Nov 2025 According to an Entrada Therapeutics media release, first patient dosed in ELEVATE-45-201 and the Company is on track to report data from the first patient cohort in mid-2026
  • 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.

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