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A Phase 1, Open Label, Single Ascending Dose Study Designed to Compare the Safety and Pharmacokinetics of Orally Administered Superoxide Dismutase Mimetic GC4711 With Intravenously Administered Superoxide Dismutase Mimetic GC4419 in Healthy Volunteers

Trial Profile

A Phase 1, Open Label, Single Ascending Dose Study Designed to Compare the Safety and Pharmacokinetics of Orally Administered Superoxide Dismutase Mimetic GC4711 With Intravenously Administered Superoxide Dismutase Mimetic GC4419 in Healthy Volunteers

Recruiting
Phase of Trial: Phase I

Latest Information Update: 24 Oct 2018

At a glance

  • Drugs Avasopasem manganese (Primary) ; GC 4711 (Primary)
  • Indications Cancer; Head and neck cancer; Stomatitis
  • Focus Adverse reactions; First in man
  • Sponsors Galera Therapeutics
  • Most Recent Events

    • 16 Oct 2018 Planned number of patients changed from 58 to 40.
    • 16 Oct 2018 Planned End Date changed from 1 Nov 2018 to 1 Feb 2019.
    • 16 Oct 2018 Planned primary completion date changed from 1 Nov 2018 to 1 Feb 2019.
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