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A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Dose Study Evaluating Safety, Tolerability, and Pharmacokinetics, With an Open-Label Initial Food Effect and CYP3A Drug-Drug Interaction Study, of FTX-6058 in Healthy Adult Subjects, and a Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study Evaluating, Safety, Tolerability and Pharmacokinetics in Subjects With Sickle Cell Disease (SCD)

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Trial Profile

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Dose Study Evaluating Safety, Tolerability, and Pharmacokinetics, With an Open-Label Initial Food Effect and CYP3A Drug-Drug Interaction Study, of FTX-6058 in Healthy Adult Subjects, and a Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study Evaluating, Safety, Tolerability and Pharmacokinetics in Subjects With Sickle Cell Disease (SCD)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Pociredir (Primary) ; Midazolam
  • Indications Sickle cell anaemia
  • Focus Adverse reactions
  • Sponsors Fulcrum Therapeutics

Most Recent Events

  • 01 May 2025 According to a Fulcrum Therapeutics media release, abstract have been accepted for presentation at the 2025 European Hematology Association (EHA) Congress in Milan, Italy, taking place on June 12-15, 2025.
  • 09 Dec 2022 Status changed from recruiting to completed.
  • 09 Sep 2022 Planned End Date changed from 1 Jun 2022 to 1 Dec 2022.

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