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NCT03762031

A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers

Completed Phase 1 Last updated 14 August 2020
What this trial tests

Phase 1 trial testing GC4711 30mg in Healthy in 70 participants. Completed in 4 March 2020.

Timeline
19 March 2019
Primary endpoint
4 March 2020
4 March 2020

Quick facts

Lead sponsorGalera Therapeutics, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingquadruple
Primary purposetreatment
Enrollment70
Start date19 March 2019
Primary completion4 March 2020
Estimated completion4 March 2020
Sites1 location across Australia

Drugs / interventions tested

Conditions studied

Sponsor

Galera Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose escalation study designed to evaluate the safety and PK of intravenously administered superoxide dismutase mimetic GC4711 in healthy volunteers.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Superoxide Dismutase 1 in Health and Disease: How a Frontline Antioxidant Becomes Neurotoxic.
    Trist BG, Hilton JB, Hare DJ, Crouch PJ, et al · · 2021 · cited 148× · PMID 32144830 · DOI 10.1002/anie.202000451
  2. Mitochondrial Oxidative Stress and Cell Death in Podocytopathies.
    Zhu YT, Wan C, Lin JH, Hammes HP, et al · · 2022 · cited 31× · PMID 35327595 · DOI 10.3390/biom12030403

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Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Galera Therapeutics, Inc. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03762031.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing