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A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose and Multi-Dose Study of DT-216 in Adult Patients With Friedreich Ataxia

Trial Profile

A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose and Multi-Dose Study of DT-216 in Adult Patients With Friedreich Ataxia

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Mar 2024

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At a glance

  • Drugs DT-216 (Primary)
  • Indications Friedreich's ataxia
  • Focus Adverse reactions; Proof of concept
  • Sponsors Design Therapeutics

Most Recent Events

  • 27 Feb 2024 Status changed from active, no longer recruiting to completed.
  • 14 Aug 2023 According to a Design Therapeutics media release, the company Expects to Resume a Multiple Dose Phase 1 Clinical Study with DT-216 with an Improved Formulation in the Second Half of 2024 and Report Data in the First Half of 2025.
  • 14 Aug 2023 According to a Design Therapeutics media release, the company has elected to complete dose escalation in this Phase 1 study at the 300mg cohort due to concern for potential worsening of injection site thrombophlebitis at higher doses with multiple administration. The company to host a live webcast and conference call today at 4:30 pm ET to discuss data from this trial.

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