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SUNCIST: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics of Intravenous Administration of Calmangafodipir in Healthy Japanese and Caucasian Subjects

Trial Profile

SUNCIST: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics of Intravenous Administration of Calmangafodipir in Healthy Japanese and Caucasian Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 16 Feb 2018

At a glance

  • Drugs Calmangafodipir (Primary)
  • Indications Chemotherapy-induced damage; Liver failure
  • Focus Adverse reactions
  • Acronyms SUNCIST
  • Sponsors PledPharma
  • Most Recent Events

    • 09 Feb 2018 Status changed from recruiting to completed.
    • 01 Dec 2017 According to a PledPharma AB media release, first set of patients have been enrolled in the study and the data form this trial will be used for an expansion of the phase III clinical program, aims to include Asian patients.
    • 01 Dec 2017 Status changed from planning to recruiting, according to a PledPharma AB media release.
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