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A Two-part Multicenter Study: a Randomized, Double-blind, Placebo-controlled Dose-escalation Safety Phase (Part 1) Followed by Double-blind, Placebo-controlled, Adaptive Phase (Part 2) Study to Evaluate the Safety and Efficacy of AB-1003 in Adult Subjects With LGMD2I/R9 Mutations in the Gene Encoding Fukutin Related Protein (FKRP)

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A Two-part Multicenter Study: a Randomized, Double-blind, Placebo-controlled Dose-escalation Safety Phase (Part 1) Followed by Double-blind, Placebo-controlled, Adaptive Phase (Part 2) Study to Evaluate the Safety and Efficacy of AB-1003 in Adult Subjects With LGMD2I/R9 Mutations in the Gene Encoding Fukutin Related Protein (FKRP)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Apr 2024

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At a glance

  • Drugs AB 1003 (Primary)
  • Indications Limb girdle muscular dystrophies
  • Focus Adverse reactions
  • Sponsors Asklepios BioPharmaceutical

    • Most Recent Events

    • 03 Aug 2023 According to an AskBio meida release, AB-1003, which is manufactured by AskBios wholly owned and independently operated subsidiary Viralgen, was granted fast track designation by the FDA and orphan drug designation by the European Commission.
    • 03 Aug 2023 According to an AskBio meida release, first patient has been dosed in this study. The trial was initiated in the US in Q2 2023.
    • 15 Mar 2023 Status changed from not yet recruiting to recruiting.

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