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A Phase 1 Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CTI-1601 Versus Placebo in Subjects With Friedreich's Ataxia

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Trial Profile

A Phase 1 Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CTI-1601 Versus Placebo in Subjects With Friedreich's Ataxia

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Nov 2022

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At a glance

  • Drugs Nomlabofusp (Primary)
  • Indications Friedreich's ataxia
  • Focus Adverse reactions; Proof of concept
  • Sponsors Larimar Therapeutics

    • Most Recent Events

    • 19 Oct 2022 According to Larimar Therapeutics media release, the data from phase I clinical program evaluating CTI-1601 for the treatment for Friedreich's Ataxia will be featured in the three presentations at the upcoming International Congress for Ataxia Research. The conference will take place from 1st-4th November 2022 in Dallas, Texas, USA.
    • 19 May 2022 According to a Larimar Therapeutics media release, data from this study will be presented at the 4th Pan American Parkinsons Disease and Movement Disorders Congress.
    • 20 May 2021 According to a Larimar Therapeutics media release, the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to CTI-1601 for the treatment of FA. The PRIME designation was based on positive data from nonclinical studies and Phase 1 clinical program in patients with FA.

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