A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 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 (Part 1), With Assessment of Food Effect (Part 2), in Healthy Volunteers

Trial Profile

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 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 (Part 1), With Assessment of Food Effect (Part 2), in Healthy Volunteers

Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 22 Nov 2017

At a glance

  • Drugs GC 4419 (Primary) ; GC 4711 (Primary)
  • Indications Cancer; Head and neck cancer; Stomatitis
  • Focus Adverse reactions; First in man
  • Sponsors Galera Therapeutics
  • Most Recent Events

    • 16 Nov 2017 Planned End Date changed from 1 Dec 2017 to 1 Nov 2018.
    • 16 Nov 2017 Planned primary completion date changed from 1 Dec 2017 to 1 Nov 2018.
    • 16 Nov 2017 Planned initiation date changed from 1 Oct 2017 to 1 Sep 2018.
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